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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 is a Phase 3 study of Bowel; Stricture that is actively recruiting participants, run by GIE Medical. The registered enrollment target is 171 participants. The trial reports 20 study locations across 12 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05561127
The ClinicalTrials.gov registry entry for NCT05561127 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 171 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GIE Medical, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.