NCT05561127ClinicalTrials.gov

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

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

Phase 3171 Teilnehmende gesucht33 Studienzentren1 Land

Kategorien

Gastroenterologie und Hepatologie45%Neurologie27%Augenheilkunde27%

In 1 Register registriert

ClinicalTrials.govNCT05561127Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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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 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.

Zusammenfassung

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

Erkrankungen

Bowel; Stricture

Eignung

Eignung
Geschlecht	Alle
Alter	22 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	SINGLE (1)
Teilnahme	171 Teilnehmende gesucht

Sponsor und Mitwirkende

GIE Medical Sponsor

Studienarme und Interventionen

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.

Interventionen

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

Endpunkte

Primärer Endpunkt
Freedom from Stricture Recurrence
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Zeitrahmen 6 Months Post-Treatment
Primärer Endpunkt
Primary Safety Outcome
Incidence of device- and/or procedure-related Major Adverse Events (MAEs) (Death, perforation of the esophagus, bleeding requiring intervention or transfusion)
Zeitrahmen 30 Days Post-Treatment
Sekundärer Endpunkt
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.
Zeitrahmen 6 Months Post-Procedure
Sekundärer Endpunkt
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.
Zeitrahmen 6 Months Post-Procedure
Sonstiger Endpunkt
Surgery Free Survival
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Improvement in GIQLI-10
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Technical Success
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Improvement in EOS
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Dilations per year before and after treatment
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Time between dilations
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years
Sonstiger Endpunkt
Estimated stricture diameter
Zeitrahmen 30 days, 3 months, 6 months, 12 months, and annually thereafter through 5 years

Daten

Daten
Startdatum	1. November 2023 (tatsächlich)
Primärer Abschluss	1. Dezember 2027 (geschätzt)
Abschluss	1. Juni 2032 (geschätzt)
Erstveröffentlichung	30. September 2022 (tatsächlich)
Zuletzt aktualisiert	25. Juni 2025
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juni 2025

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

32 Studienzentren rekrutieren

United States

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

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

https://xmedica.io/trials/ctgov/NCT05561127