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NCT06190717ClinicalTrials.gov

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.

התערבותידרושים 304 משתתפים21 אתריםמדינה אחת

קטגוריות

אנדוקריני ומטבולי48%נפרולוגיה ואורולוגיה44%מיילדות וגינקולוגיה8%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2024-01-05; recorded start 2024-02-21
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Sonavex, Inc.)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 21 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 304 participants (target), run at 21 sites.

How this score is built
  • Enrolment24/40

    304 participants (target)

  • Site count16/25

    21 sites

  • Country count0/15

    Single country

  • Planned duration8/10

    Planned over about 36 months

  • Sponsor scale0/10

    Sonavex, Inc. has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.

מצבים רפואיים

  • End Stage Renal Disease
  • Diabetes

זכאות

מיןהכול
גילאים18 Years – 84 Years
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: * Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent. * Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures. * Subject is willing and capable of complying with all required follow-up visits. * Subject and/or Care Team agree that the distance and transportation resources from the patient's home to the clinic are reasonable for study participation and compliance. * Subject has an estimated life expectancy \> 18 months. * Subject is ambulatory (cane or walker are acceptable). * CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access. * Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR \<10). * Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping. * Artery diameter ≥ 2.5 mm per vein mapping. * Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable. Exclusion Criteria: * CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access. * Subject has history of Steal Syndrome. * Subject who is immunocompromised or immunosuppressed. * Subject has had three previous failed AV fistulae for hemodialysis access. * Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation. * Known or suspected active infection on the day of the index procedure. * Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula. * Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access. * Subjects with active malignancy. * Subjects with a history of poor compliance with the dialysis protocol. * Subjects with a known or suspected allergy to any of the device materials. * Subjects with an existing fistula or graft. * Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months. * Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבלא רלוונטי
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהNONE (0)
גיוסדרושים 304 משתתפים

נותן חסות ושותפים

  • Sonavex, Inc. נותן חסות

זרועות והתערבויות

  • Diagnostic ArmEXPERIMENTAL

    All subjects will have the EchoMark implanted. Subjects will be assessed every 2 weeks (+/- 1 week) (but no more frequently than weekly) with the EchoSure system until fistula maturation occurs and/or permanent access use is achieved.

  • Standard of CareACTIVE_COMPARATOR

    Subjects will be evaluated per KDOQI guidelines (with physical examination at approximately 2 weeks (+/- 1 week) and between 4 and 6 weeks (+/- 1 week)). If evaluation yields abnormal findings, subjects will receive a Duplex ultrasound assessment (DUS). All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.

התערבויות

  • התקן EchoMark/EchoSure

    Subjects assigned to the Diagnostic Arm will have the EchoMark implanted at the time of AVF creation. The subject will return every 2 weeks for a follow-up assessment to include an EchoSure scan until fistula maturation and/or permanent access use is achieved. The EchoSure scans are to be reviewed by the investigator(s) or delegated study staff and aid in the determination when a further assessment, including a physical exam, is required to determine cannulation clearance or if an intervention(s) may be required to prevent failure of fistula maturation. All physical exams will include assessing the fistula for bruit and thrill. The subject's medical history will be reviewed at each visit and will include all interventions, cannulation attempts, and adverse event reporting.

  • פרוצדורה Standard of Care

    Subjects are assessed using standard of care per KDOQI guidelines, which includes a physical exam at the 2-week follow-up visit and at the 4-6-week follow-up visit. All follow-up visits will include an assessment of adverse events and medical history review to include all interventions, cannulation attempts, and laboratory results. If evaluation yields an abnormal finding, subjects will undergo a Duplex ultrasound assessment and treatment under the institution's standard of care. All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Primary Safety Endpoint

    Freedom from the following through 6 months as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV/ 4. Complication requiring explantation of the EchoMark implant.

    מסגרת זמן 6 months

  2. מדד תוצאה ראשוני

    Primary Effectiveness Endpoint

    Time to clinical maturation

    מסגרת זמן 6 months

  3. מדד תוצאה משני

    Difference between EchoSure and Duplex Flow Measurements

    Difference between log10-transformed EchoSure and Duplex flow measurements of blood flow for assessment of measurement agreement in the diagnostic arm.

    מסגרת זמן 6 Months

  4. מדד תוצאה משני

    EchoSure Depth Comparison

    Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.

    מסגרת זמן 6 Months

  5. מדד תוצאה משני

    EchoSure Diameter Comparison

    Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.

    מסגרת זמן 6 Months

  6. מדד תוצאה משני

    EchoMark/EchoSure System Technical Success

    Technical Success defined as the successful implantation of the EchoMark implant and the ability to complete each scan to determine the blood flow, diameter, and depth measurements at the EchoMark using the EchoSure diagnostic ultrasound system from baseline to Clinical Maturation, fistula failure, or 4 months, whichever is sooner.

    מסגרת זמן 4 Months

  7. מדד תוצאה משני

    CVC Removal

    Time to CVC removal by subject group

    מסגרת זמן 6 Months

  8. מדד תוצאה משני

    Rate of Hospitalization

    Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.

    מסגרת זמן 6 Months

  9. מדד תוצאה משני

    AV Fistula Maturation Rate

    Percent of AVFs created that mature by 180 days by subject group.

    מסגרת זמן 6 Months

  10. מדד תוצאה משני

    Total Cost of Care

    Total cost of care, defined by National average Medicare payment rate (facility and professional fees) for procedures and care provided to subject by subject group from baseline to Clinical Maturation.

    מסגרת זמן 6 Months

  11. מדד תוצאה משני

    Freedom from Events through 30 and 90 Days

    Freedom from the following through 30 and 90 days from the baseline procedure as adjudicated by the CEC: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure of the implant over time, requiring surgical intervention. 3. Infection of tissues surrounding the EchoMark implant requiring IV antibiotic treatment. 4. Complication requiring explantation of the EchoMark implant.

    מסגרת זמן 30 Days and 90 Days

  12. מדד תוצאה אחר

    Hierarchical Composite 1

    Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Fistula creation success.

    מסגרת זמן 6 Months

  13. מדד תוצאה אחר

    Hierarchical Composite 2

    Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Alive through 180 days.

    מסגרת זמן 6 Months

  14. מדד תוצאה אחר

    Hierarchical Composite 3

    Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Freedom from SAE with 180 days (severity as a tie-breaker for SAEs with matching adverse event term)

    מסגרת זמן 6 Months

  15. מדד תוצאה אחר

    Hierarchical Composite 4

    Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Earlier time to AV fistula Clinical Maturation with 180 days.

    מסגרת זמן 6 Months

  16. מדד תוצאה אחר

    Comparison of Composite and Stratified MAE Rates

    Comparison of composite and stratified MAE rates for both subject groups at 6 months and end of study. MAEs are adjudicated by the CEC and defined as any of the following: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure or the implant over time, requiring surgical intervention. 3. Complication requiring explantation of the EchoMark implant. 4. Clinically significant surgical complications (seroma, edema, hematoma, bleeding), excluding expected resorption response visible as hypoechoic region on B-mode ultrasound. 5. Infection requiring IV antibiotic treatment. Pseudoaneurysm. 6. Thrombosis of the AVF circuit that requires an intervention (surgical or endovascular). 7. Steal Syndrome.

    מסגרת זמן 6 Months and 12 Months

  17. מדד תוצאה אחר

    Comparision of Implant and Procedure Related Adverse Events

    Comparison of all stratified implant and procedure related AE (as adjudicated by the CEC) rates between subject groups at 6 months and end of study.

    מסגרת זמן 6 Months and 12 Months

  18. מדד תוצאה אחר

    Clinical Maturation

    Percent of subjects that have reached Clinical Maturation (as adjudicated by the CEC) for each subject group at 90 days, 120 day, 150 days, and 180 days.

    מסגרת זמן 3 Months, 4 Months, 5 Months, and 6 Months

  19. מדד תוצאה אחר

    Cannulation Complication Rates

    Comparison of composite and stratified cannulation complication (as adjudicated by the CEC) rates between subject groups for the following AEs: 1. Infection due to cannulation. 2. Thrombosis due to hematoma. 3. Any other AE determined by the CEC to be cannulation related.

    מסגרת זמן 12 Months

  20. מדד תוצאה אחר

    Time to Clinical Maturation for Procedure and Device Related Events

    Distribution of time to Clinical Maturation for both groups for each of the following procedure and device related categories presented as violin/box plots: 1. Clinically significant misplacement or migration of the EchoMark implant. 2. Vessel or tissue injury caused by the EchoMark implant procedure or the implant over time, requiring surgical intervention. 3. Clinically significant surgical complications (seroma, edema, hematoma, bleeding), excluding expected resorption response visible as hypoechoic region on B-mode ultrasound. 4. Infection requiring IV antibiotic treatment. 5. Pseudoaneurysm. 6. Thrombosis of AVF circuit requiring an intervention (surgical or endovascular). 7. Steal Syndrome. 8. No SAE.

    מסגרת זמן 6 Months

  21. מדד תוצאה אחר

    Primary Functional Patency

    Primary functional patency at 6 months (as adjudicated by the CEC) defined as freedom from intervention on the AVF after maturation.

    מסגרת זמן 6 Months

  22. מדד תוצאה אחר

    Secondary Function Patency

    Secondary functional patency at 6 months (as adjudicated by the CEC) is defined as freedom from abandonment of the AVF after maturation.

    מסגרת זמן 6 Months

  23. מדד תוצאה אחר

    Time to Clinical Maturation

    Time to Clinical Maturation (as adjudicated by the CEC) defined as the time from initial fistula creation to Clinical Maturation.

    מסגרת זמן 6 Months

  24. מדד תוצאה אחר

    Time to Clinical Maturation for Each Fistula

    Time to Clinical Maturation (as adjudicated by the CEC) for each new fistula defined as the time from new fistula creation to Clinical Maturation.

    מסגרת זמן 6 Months

  25. מדד תוצאה אחר

    Technical Success Cannulation Scans

    Rate of cannulation zone technical success rate defined as the ability to complete each scan to determine the diameter, and depth measurements at the proximal, mid, and distal segments of the fistula using the EchoSure diagnostic ultrasound system from the 2-week follow-up to Clinical Maturation, or 4 months, whichever is sooner.

    מסגרת זמן 4 Months

  26. מדד תוצאה אחר

    EchoSure Diameter and Depth Comparison in Cannulation Zone

    Agreement of EchoSure diameter and depth results from the cannulation zone at the 6-week follow-up compared to the CoreLab measured diameter and depth results in the DIAG arm.

    מסגרת זמן 6 Months

  27. מדד תוצאה אחר

    Intervention to Assist Maturation Rate

    Surgical or Endovascular Interventions to Assist Maturation defined as the difference between groups in the proportion of subjects with surgical or endovascular interventions to assist maturation.

    מסגרת זמן 6 Months

תאריכים

תאריך התחלה21 בפברואר 2024 (בפועל)
סיום ראשוני1 בפברואר 2027 (משוער)
סיום1 בפברואר 2027 (משוער)
פורסם לראשונה5 בינואר 2024 (בפועל)
עודכן לאחרונה13 באפריל 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהיוני 2025

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

20 אתרים מגייסים

United States

מתקןעירמדינה או אזורמצב
HealthQare AssociatesArlingtonVirginiaמגייס
Boston Medical CenterBostonMassachusettsמגייס
Galen Medical GroupChattanoogaTennesseeמגייס
Northwestern UniversityChicagoIllinoisמגייס
Atrium HealthConcordNorth Carolinaמגייס
Baylor Scott & White Heart and Vascular HospitalDallasTexasמגייס
Trinity Research GroupDothanAlabamaמגייס
Prisma HealthGreenvilleSouth Carolinaמגייס
Aqua Research Institute LlcHoustonTexasמגייס
MSU Health Care Heart and VascularLansingMichiganמגייס
Fresenius Vascular Care Memphis MSOMemphisTennesseeהופסק
Northwell HealthNew Hyde ParkNew Yorkמגייס
Medical University of South Carolina Health OrangeburgOrangeburgSouth Carolinaמגייס
Orlando Health Heart and Vascular InstituteOrlandoFloridaמגייס
Capital Medical CenterPenningtonNew Jerseyמגייס
Southwest Kidney InstitutePhoenixArizonaמגייס
AKDHC Medical Research ServicesPhoenixArizonaמגייס
Physicians Care of VirginiaRoanokeVirginiaמגייס
AKDHC Center TucsonTucsonArizonaמגייס
Sentara HealthVirginia BeachVirginiaמגייס
Kansas Nephrology Research InstituteWichitaKansasמגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06190717