NCT06190717ClinicalTrials.gov

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.

التواصل مع هذه الدراسة

باختصار

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.

تدخّليةمطلوب 304 مشاركين21 موقعاًدولة واحدة

الفئات

الغدد الصمّاء والأيض48%الكلى والمسالك البولية44%التوليد وأمراض النساء8%

مسجَّلة في سجل واحد

ClinicalTrials.govNCT06190717فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين

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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.

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

ملخص

الحالات

End Stage Renal Disease
Diabetes

الأهلية

الأهلية
الجنس	الجميع
الأعمار	18 Years – 84 Years
المتطوعون الأصحّاء	لا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسة	تدخّلية
المرحلة	غير منطبق
التخصيص	معشّاة
نموذج التدخّل	PARALLEL
الغرض الأساسي	TREATMENT
التعمية	NONE (0)
التجنيد	مطلوب 304 مشاركين

الجهة الراعية والمتعاونون

Sonavex, Inc. الجهة الراعية

الأذرع والتدخلات

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.

التدخلات

جهاز 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.
إجراء 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.

مقاييس النتائج

مقياس النتيجة الأولي
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.
الإطار الزمني 6 months
مقياس النتيجة الأولي
Primary Effectiveness Endpoint
Time to clinical maturation
الإطار الزمني 6 months
مقياس النتيجة الثانوي
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.
الإطار الزمني 6 Months
مقياس النتيجة الثانوي
EchoSure Depth Comparison
Difference between EchoSure and CoreLab measurements of depth for assessment of measurement agreement in the diagnostic arm.
الإطار الزمني 6 Months
مقياس النتيجة الثانوي
EchoSure Diameter Comparison
Difference between EchoSure and CoreLab measurement of diameter for assessment of measurement agreement in the diagnostic arm.
الإطار الزمني 6 Months
مقياس النتيجة الثانوي
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.
الإطار الزمني 4 Months
مقياس النتيجة الثانوي
CVC Removal
Time to CVC removal by subject group
الإطار الزمني 6 Months
مقياس النتيجة الثانوي
Rate of Hospitalization
Rate of hospitalization(s) by subject group from baseline to Clinical Maturation.
الإطار الزمني 6 Months
مقياس النتيجة الثانوي
AV Fistula Maturation Rate
Percent of AVFs created that mature by 180 days by subject group.
الإطار الزمني 6 Months
مقياس النتيجة الثانوي
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.
الإطار الزمني 6 Months
مقياس النتيجة الثانوي
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.
الإطار الزمني 30 Days and 90 Days
مقياس نتيجة آخر
Hierarchical Composite 1
Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Fistula creation success.
الإطار الزمني 6 Months
مقياس نتيجة آخر
Hierarchical Composite 2
Hierarchical composite of the DIAG arm and SOC arm comparing occurrences of: Alive through 180 days.
الإطار الزمني 6 Months
مقياس نتيجة آخر
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)
الإطار الزمني 6 Months
مقياس نتيجة آخر
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.
الإطار الزمني 6 Months
مقياس نتيجة آخر
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.
الإطار الزمني 6 Months and 12 Months
مقياس نتيجة آخر
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.
الإطار الزمني 6 Months and 12 Months
مقياس نتيجة آخر
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.
الإطار الزمني 3 Months, 4 Months, 5 Months, and 6 Months
مقياس نتيجة آخر
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.
الإطار الزمني 12 Months
مقياس نتيجة آخر
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.
الإطار الزمني 6 Months
مقياس نتيجة آخر
Primary Functional Patency
Primary functional patency at 6 months (as adjudicated by the CEC) defined as freedom from intervention on the AVF after maturation.
الإطار الزمني 6 Months
مقياس نتيجة آخر
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.
الإطار الزمني 6 Months
مقياس نتيجة آخر
Time to Clinical Maturation
Time to Clinical Maturation (as adjudicated by the CEC) defined as the time from initial fistula creation to Clinical Maturation.
الإطار الزمني 6 Months
مقياس نتيجة آخر
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.
الإطار الزمني 6 Months
مقياس نتيجة آخر
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.
الإطار الزمني 4 Months
مقياس نتيجة آخر
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.
الإطار الزمني 6 Months
مقياس نتيجة آخر
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.
الإطار الزمني 6 Months

التواريخ

التواريخ
تاريخ البدء	21 فبراير 2024 (فعلي)
الإتمام الأولي	1 فبراير 2027 (تقديري)
الإتمام	1 فبراير 2027 (تقديري)
أول نشر	5 يناير 2024 (فعلي)
آخر تحديث	13 أبريل 2026
النتائج منشورة	غير مذكور في سجل السجل
آخر تأكيد للحالة	يونيو 2025

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

20 موقعاً قيد التجنيد

United States

United States
المنشأة	المدينة	الولاية أو المنطقة	الحالة
HealthQare Associates	Arlington	Virginia	قيد التجنيد
Boston Medical Center	Boston	Massachusetts	قيد التجنيد
Galen Medical Group	Chattanooga	Tennessee	قيد التجنيد
Northwestern University	Chicago	Illinois	قيد التجنيد
Atrium Health	Concord	North Carolina	قيد التجنيد
Baylor Scott & White Heart and Vascular Hospital	Dallas	Texas	قيد التجنيد
Trinity Research Group	Dothan	Alabama	قيد التجنيد
Prisma Health	Greenville	South Carolina	قيد التجنيد
Aqua Research Institute Llc	Houston	Texas	قيد التجنيد
MSU Health Care Heart and Vascular	Lansing	Michigan	قيد التجنيد
Fresenius Vascular Care Memphis MSO	Memphis	Tennessee	أُنهي
Northwell Health	New Hyde Park	New York	قيد التجنيد
Medical University of South Carolina Health Orangeburg	Orangeburg	South Carolina	قيد التجنيد
Orlando Health Heart and Vascular Institute	Orlando	Florida	قيد التجنيد
Capital Medical Center	Pennington	New Jersey	قيد التجنيد
Southwest Kidney Institute	Phoenix	Arizona	قيد التجنيد
AKDHC Medical Research Services	Phoenix	Arizona	قيد التجنيد
Physicians Care of Virginia	Roanoke	Virginia	قيد التجنيد
AKDHC Center Tucson	Tucson	Arizona	قيد التجنيد
Sentara Health	Virginia Beach	Virginia	قيد التجنيد
Kansas Nephrology Research Institute	Wichita	Kansas	قيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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