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NCT05561127 · ClinicalTrials.gov registry record · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel
A Phase 3 study of Bowel; Stricture, sponsored by GIE Medical.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 171
- Enrollment target
- 20
- Study locations
NCT05561127: Recruiting Phase 3 study of Bowel; Stricture, sponsored by GIE Medical.
NCT05561127 is a Phase 3 study of Bowel; Stricture that is actively recruiting participants, run by GIE Medical. The registered enrollment target is 171 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05561127, a Phase 3 study of Bowel; Stricture, is actively recruiting participants, sponsored by GIE Medical.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 171 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
Primary Outcome
Endoscopic Obstruction Scale (EOS) of \> 1 when using a pediatric colonoscope or equivalent
Conditions Studied
Interventions
- OTHER Control
- COMBINATION_PRODUCT GIE Medical ProTractX3 TTS DCB
Study Locations (20)
Florida
- University of Florida - Gainesville
- Borland-Groover - Jacksonville
- Research Associates of South Florida - Miami
- Hillcrest Medical Research - Orange City
- Orlando Health - Orlando
- Orlando Health - Orlando
California
- University of California, Irvine - Irvine
- Gastro Care Institute - Lancaster
- Cedars Sinai - Los Angeles
- San Diego Gastroenterology - San Diego
Arizona
- Honor Health - Scottsdale
Colorado
- University of Colorado Anschutz - Aurora
Georgia
- Gastroenterology Associates of Central Georgia, LLC - Macon
Illinois
- Rush University - Chicago
Kansas
- Kansas Gastroenterology, LLC - Wichita
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2032-06-01 |
| Phase | Phase 3 |
What NCT05561127 shows while recruiting
NCT05561127 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Bowel; Stricture appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT05561127 names 20 study sites across 12 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05561127 about?
NCT05561127 is a clinical study titled "Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Bowel". To determine the safety and efficacy of GIE Medical's ProTractX3™ TTS DCB for the treatment of recurrent benign bowel strictures.
What is the current status of trial NCT05561127?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 171 participants. The study started on 2023-11-01. Estimated completion is 2032-06-01.
What conditions does trial NCT05561127 study?
This clinical trial studies the following conditions: Bowel; Stricture.
What interventions are being tested in trial NCT05561127?
The interventions under investigation include: Control (OTHER), GIE Medical ProTractX3 TTS DCB (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05561127?
This trial is sponsored by GIE Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05561127 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05561127's enrollment target sits among peer trials
171 1452nd of 2000 higher than 548 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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