xMedica

NCT05561114ClinicalTrials.gov

Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus

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

בקצרה

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

שלב 3דרושים 198 משתתפים34 אתריםמדינה אחת

קטגוריות

גסטרואנטרולוגיה והפטולוגיה100%

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 2022-09-30; recorded start 2023-12-01
  • 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
  • Uses blinding (masking)A masking level is recorded in the record
  • 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
  • Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (GIE Medical)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

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 phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding7/20

    Single-blind

  • 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: 34 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

ScaleSMALL

A small study: 198 participants (target), run at 34 sites.

How this score is built
  • Enrolment22/40

    198 participants (target)

  • Site count18/25

    34 sites

  • Country count0/15

    Single country

  • Planned duration10/10

    Planned over about 89 months

  • Sponsor scale2/10

    GIE Medical has led 4 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

To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.

מצבים רפואיים

  • Esophageal Stricture

זכאות

מיןהכול
גילאים22 Years – ללא מקסימום
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: 1. Age ≥ 22 years 2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations 3. Ogilvie Dysphagia Score of ≥2 4. Minimum esophageal lumen diameter \<13 mm 5. Willing and able to complete protocol required follow-up visits 6. Willing and able to provide written informed consent 7. Strictures ≤5cm in total length 8. Target benign esophageal stricture etiologies include: 1. Peptic stricture, 2. Schatzki's ring, 3. Stricture due to prior infection, 4. Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture 5. Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy Exclusion Criteria: 1. Two or more clinically significant (e.g. non-traversable) strictures with total length \>5cm or unable to be treated with a single balloon. 2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months 3. Contraindication to endoscopy, anesthesia or deep sedation 4. Benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, lichen planus, and purely radiation induced strictures post head/neck cancer treatment. 5. History of diagnosis of eosinophilic esophagitis (EoE) 6. Signs or suspicion of a malignant esophageal stricture NOTE: If stricture is suspicious for malignancy based on clinical or endoscopic presentation, malignancy must be excluded by biopsy prior to enrollment. Subjects with a history of invasive esophageal cancer should have recurrence excluded by advanced imaging (e.g. CT/PET scan) and biopsy within 6 months of enrollment. 7. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the neck or thoracic region NOTE: A prior diagnosis of esophageal cancer is acceptable if considered in remission and recurrence has been excluded by advanced imaging and biopsy within 6 months of enrollment. 8. Suspected perforation of gastrointestinal tract 9. Inability to pass guidewire across stricture 10. Active systemic infection 11. Allergy to paclitaxel or structurally related compounds 12. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure 13. Chronic systemic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use 14. Received steroid injections into target stricture in the last 8 weeks. 15. Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of the investigator 16. Current use of nasal or oral feeding tube unless tube is removed prior to baseline assessments and subject maintains normal swallowing function. 17. Acute stricture condition that requires emergent procedure (e.g. immediate dilation) 18. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakage or varices, or thrombosis, etc 19. Life expectancy of less than 24 months 20. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety, such as recent myocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracic aneurysm, pharyngeal or cervical deformity, ongoing infection, etc 21. Current participation in another pre-market drug or medical device clinical study that has not reached it's primary endpoint. 22. Dysphagia related to primary motility disorders, such as achalasia, diffused esophageal spasm, ineffective esophageal motility (IEM), hypertensive lower esophageal sphincter, esophageal outlet obstruction, etc. 23. Active erosive esophagitis with a Los Angeles classification of Grade B-D at the time of endoscopy. 24. Significant esophageal dilation proximal to the stricture that, in the Investigator's opinion, may impact long-term esophageal motility. 25. Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2 receptor antagonists) 26. Concurrent gastric and/or duodenal obstruction

זכאות במשפטים פשוטים

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

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהSINGLE (1)
גיוסדרושים 198 משתתפים

נותן חסות ושותפים

  • GIE Medical נותן חסות

זרועות והתערבויות

  • ControlACTIVE_COMPARATOR

    Standard of Care Endoscopic Dilation

  • GIE Medical ProTractX3 TTS DCBEXPERIMENTAL

    The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

התערבויות

  • אחר Control

    Standard Endoscopic Dilation

  • מוצר משולב GIE Medical ProTractX3 TTS DCB

    Paclitaxel Coated Balloon

מדדי תוצאה

  1. מדד תוצאה ראשוני

    Treatment Success

    1\. The primary efficacy endpoint is freedom from stricture recurrence, measured as the time from Index procedure until stricture recurrence through 6 months post-procedure. Stricture recurrence is defined as an esophageal diameter \<13mm as measured using a functional luminal imaging probe, or clinically driven reintervention at the treated area within 6 months post-procedure as determined by the Clinical Events Committee

    מסגרת זמן 6 Months Post-Procedure

  2. מדד תוצאה ראשוני

    Primary Safety Outcome

    Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)

    מסגרת זמן 30 Days Post-Treatment

  3. מדד תוצאה משני

    Annualized Rate of Reintervention

    The annualized reintervention rate is defined as the annualized number of clinically driven interventions and will be assessed by comparing the annualized rate per patient year between groups using a test of Poisson rates.

    מסגרת זמן Annually

  4. מדד תוצאה משני

    Diameter Improvement at 6 months

    The minimum esophageal stricture diameter will be assessed by a functional luminal imaging probe (EndoFLIP) during endoscopy and compared between the Test and Control arms. The minimum esophageal stricture diameter will be measured at baseline and during the 6-month follow-up, or at the time of a reintervention if one occurs prior to 6 months.

    מסגרת זמן 6 Months Post-Procedure

  5. מדד תוצאה משני

    Clinical Responder Rate at 6 months

    מסגרת זמן 6 Months Post-Procedure

  6. מדד תוצאה משני

    Freedom from clinically driven target stricture reintervention through 6 months post-procedure

    מסגרת זמן 6 Months Post-Procedure

  7. מדד תוצאה משני

    Freedom from symptom recurrence through 6 months post-procedure

    מסגרת זמן 6 Months Post-Procedure

  8. מדד תוצאה אחר

    Secondary Patency

    מסגרת זמן Time between the index procedure to the second clinically driven intervention

  9. מדד תוצאה אחר

    Technical Success

    מסגרת זמן Procedure

  10. מדד תוצאה אחר

    Annualized rate of dilations before and after treatment

    מסגרת זמן Annually

  11. מדד תוצאה אחר

    Improvement in time between dilations

    מסגרת זמן Between Dilations

  12. מדד תוצאה אחר

    Improvement in Ogilvie Dysphagia Score at each follow-up

    מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  13. מדד תוצאה אחר

    Improvement in Dysphagia Handicap Index score at each follow-up

    מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  14. מדד תוצאה אחר

    Stricture characteristics per functional imaging

    מסגרת זמן Between Dilations

  15. מדד תוצאה אחר

    Number of esophageal dilation procedures through each follow up

    מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  16. מדד תוצאה אחר

    Freedom from clinically driven reintervention through each follow-up

    מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  17. מדד תוצאה אחר

    Freedom from symptom recurrence through each follow-up

    מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  18. מדד תוצאה אחר

    VAS for pain scores through 30-day follow-up

    מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

  19. מדד תוצאה אחר

    Composite EQ-5D quality of life scores at each follow-up

    מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

תאריכים

תאריך התחלה1 בדצמבר 2023 (בפועל)
סיום ראשוני1 באוקטובר 2026 (משוער)
סיום1 באפריל 2031 (משוער)
פורסם לראשונה30 בספטמבר 2022 (בפועל)
עודכן לאחרונה25 ביוני 2025
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

33 אתרים מגייסים

United States

מתקןעירמדינה או אזורמצב
University of Colorado AnschutzAuroraColoradoמגייס
Birmingham Gastroenterology AssociatesBirminghamAlabamaטרם מגייס
Brigham and Women's HospitalBostonMassachusettsמגייס
University of North Carolina Chapel HillChapel HillNorth Carolinaמגייס
Rush UniversityChicagoIllinoisמגייס
University of FloridaGainesvilleFloridaמגייס
Baylor St. Luke's Medical CenterHoustonTexasמגייס
University of California, IrvineIrvineCaliforniaמגייס
Borland-GrooverJacksonvilleFloridaמגייס
Gastro Care InstituteLancasterCaliforniaמגייס
Sierra Clinical ResearchLas VegasNevadaמגייס
Cedars SinaiLos AngelesCaliforniaמגייס
University of LouisvilleLouisvilleKentuckyמגייס
Gastroenterology Associates of Central Georgia, LLCMaconGeorgiaמגייס
Tandem Clinical ResearchMarreroLouisianaמגייס
Research Associates of South FloridaMiamiFloridaמגייס
West Virginia UniversityMorgantownWest Virginiaמגייס
Vanderbilt University Medical CenterNashvilleTennesseeמגייס
New York Presbyterian Hospital- Columbia University Medical CenterNew YorkNew Yorkמגייס
Hillcrest Medical ResearchOrange CityFloridaמגייס
Orlando HealthOrlandoFloridaמגייס
University of PennsylvaniaPhiladelphiaPennsylvaniaמגייס
Thomas Jefferson UniversityPhiladelphiaPennsylvaniaמגייס
Einstein Medical CenterPhiladelphiaPennsylvaniaמגייס
Rutgers UniversityPiscatawayNew Jerseyמגייס
Allegheny Health NetworkPittsburghPennsylvaniaמגייס
TEN20 Clinical ResearchPlanoTexasמגייס
Oregon Health and Science UniversityPortlandOregonמגייס
The University of UtahSalt Lake CityUtahמגייס
San Diego GastroenterologySan DiegoCaliforniaמגייס
Honor HealthScottsdaleArizonaמגייס
Swedish Medical CenterSeattleWashingtonמגייס
Washington UniversitySt LouisMissouriמגייס
Kansas Gastroenterology, LLCWichitaKansasמגייס

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/NCT05561114