NCT05561127ClinicalTrials.gov

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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

שלב 3דרושים 171 משתתפים33 אתריםמדינה אחת

קטגוריות

גסטרואנטרולוגיה והפטולוגיה45%נוירולוגיה27%רפואת עיניים27%

רשום במרשם אחד

ClinicalTrials.govNCT05561127פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים

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.

Present: Registered before enrolment beganFirst posted 2022-09-30; recorded start 2023-11-01
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
Present: Uses blinding (masking)A masking level is recorded in the record
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
Present: Sponsor has 3 other studies in this databaseCounted from the lead sponsor named in the record (GIE Medical)
Not stated: 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 type7/10
Clinical-event endpoint
Multi-centre8/8
Multi-centre: 33 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: 171 participants (target), run at 33 sites.

How this score is built

Enrolment21/40
171 participants (target)
Site count18/25
33 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 105 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 determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.

מצבים רפואיים

Bowel; Stricture

זכאות

זכאות
מין	הכול
גילאים	22 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: 1. Age ≥ 22 2. Diagnosis of symptomatic benign bowel stricture with at least 2 previous dilations. 3. Willing and able to complete protocol required follow up 4. Willing and able to provide written informed consent 5. Stricture length ≤ 5 cm Exclusion Criteria: 1. Female subjects who are pregnant or breastfeeding or plan to get pregnant in next 12 months 2. Contraindication to endoscopy, anesthesia, or deep sedation. 3. Suspicion of malignant bowel stricture NOTE: Biopsy should be taken for every stricture during the initial endoscopy, however endoscopic balloon dilation may proceed without awaiting results if suspicion for malignancy is low in the opinion of the investigator. 4. Benign stricture due to extrinsic compression 5. Stricture is not amenable to standard balloon dilation (e.g. severe angulation, unable to pass guidewire, etc.) 6. Stricture complicated with abscess, fistula, perforation, leakage or varices 7. Stricture segment has moderate to severe active inflammation at the time of treatment. Moderate to severe inflammation is defined as any one of; ulcers \>0.5cm in diameter, ulcerated surface \>10%, affected (inflamed) surface \>50%, marked erythema, absent vascular pattern, significant friability, or erosions 8. Multiple clinically significant strictures unable to be treated with a single balloon (i.e. total segment length must be ≤5cm) NOTE: Clinically significant strictures include those that are unable to be passed by the endoscope. 9. Received steroid injections into target stricture in the last 8 weeks 10. Stricture is not able to be dilated to ≥15mm in small bowel or ≥18mm in large bowel 11. Diagnosis of metastatic cancer of any type that is not considered in remission or non-metastatic cancer that may require radiation treatment in the pelvic region (e.g. prostate cancer) 12. Suspected perforation of gastrointestinal tract 13. Active systemic infection 14. Allergy to paclitaxel 15. Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per relevant societal guidelines 16. Chronic systemic steroid use (defined as greater than 10 mg/day) for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use 17. Condition requiring treatment in urgent setting 18. Life expectancy of less than 24 months 19. 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, etc. 20. Current participation in another pre-market drug or medical device clinical study unless in long term follow-up

זכאות במשפטים פשוטים

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

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	שלב 3
הקצאה	אקראי
מודל ההתערבות	PARALLEL
מטרה ראשית	TREATMENT
הסתרה	SINGLE (1)
גיוס	דרושים 171 משתתפים

נותן חסות ושותפים

GIE Medical נותן חסות

זרועות והתערבויות

GIE Medical ProTractX3 TTS DCBEXPERIMENTAL
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.
ControlACTIVE_COMPARATOR
Standard of Care.

התערבויות

אחר Control
Standard of Care Endoscopic Dilation
מוצר משולב GIE Medical ProTractX3 TTS DCB
The ProTractX3 Drug-coated balloon is a 0.035" guidewire compatible over-the-wire catheter.

מדדי תוצאה

מדד תוצאה ראשוני
Freedom from Stricture Recurrence
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
מסגרת זמן 6 Months Post-Treatment
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
מדד תוצאה משני
Freedom from clinically driven target stricture reintervention
Freedom from clinically driven reintervention represents freedom from repeat dilation, incision, or surgical management of the target stricture for recurrent obstructive symptoms.
מסגרת זמן 6 Months Post-Procedure
מדד תוצאה משני
Improvement in GIQLI-10 score
The Gastrointestinal Quality of Life Index (GIQLI) is a validated questionnaire developed as a health-related quality of life assessment tool for patients with gastrointestinal diseases. The items on the GIQLI-10 align closely with common obstructive symptoms found in patients with bowel strictures.
מסגרת זמן 6 Months Post-Procedure
מדד תוצאה אחר
Surgery Free Survival
מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
מדד תוצאה אחר
Improvement in GIQLI-10
מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
מדד תוצאה אחר
Technical Success
מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
מדד תוצאה אחר
Improvement in EOS
מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
מדד תוצאה אחר
Dilations per year before and after treatment
מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
מדד תוצאה אחר
Time between dilations
מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
מדד תוצאה אחר
Estimated stricture diameter
מסגרת זמן 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

תאריכים

תאריכים
תאריך התחלה	1 בנובמבר 2023 (בפועל)
סיום ראשוני	1 בדצמבר 2027 (משוער)
סיום	1 ביוני 2032 (משוער)
פורסם לראשונה	30 בספטמבר 2022 (בפועל)
עודכן לאחרונה	25 ביוני 2025
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	יוני 2025

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

מיקומים

32 אתרים מגייסים

United States

United States
מתקן	עיר	מדינה או אזור	מצב
University of Colorado Anschutz	Aurora	Colorado	מגייס
Brigham and Women's Hospital	Boston	Massachusetts	מגייס
University of North Carolina	Chapel Hill	North Carolina	מגייס
Rush University	Chicago	Illinois	מגייס
University of Florida	Gainesville	Florida	מגייס
Baylor St. Luke's Medical Center	Houston	Texas	מגייס
University of California, Irvine	Irvine	California	מגייס
Borland-Groover	Jacksonville	Florida	מגייס
Gastro Care Institute	Lancaster	California	מגייס
Cedars Sinai	Los Angeles	California	מגייס
University of Louisville	Louisville	Kentucky	מגייס
Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia	מגייס
Tandem Clinical Research	Marrero	Louisiana	מגייס
Research Associates of South Florida	Miami	Florida	מגייס
West Virginia University	Morgantown	West Virginia	מגייס
Vanderbilt University Medical Center	Nashville	Tennessee	מגייס
Lenox Hill Hospital	New York	New York	מגייס
New York Presbyterian Hospital- Columbia University Medical Center	New York	New York	מגייס
Hillcrest Medical Research	Orange City	Florida	טרם מגייס
Orlando Health	Orlando	Florida	מגייס
Orlando Health	Orlando	Florida	מגייס
University of Pennsylvania	Philadelphia	Pennsylvania	מגייס
Einstein Medical Center	Philadelphia	Pennsylvania	מגייס
Thomas Jefferson University	Philadelphia	Pennsylvania	מגייס
Rutgers University	Piscataway	New Jersey	מגייס
Allegheny Health Network	Pittsburgh	Pennsylvania	מגייס
The University of Utah	Salt Lake City	Utah	מגייס
San Diego Gastroenterology	San Diego	California	מגייס
Honor Health	Scottsdale	Arizona	מגייס
Virginia Mason	Seattle	Washington	מגייס
Swedish Medical Center	Seattle	Washington	מגייס
Washington University	St Louis	Missouri	מגייס
Kansas Gastroenterology, LLC	Wichita	Kansas	מגייס

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/NCT05561127