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NCT05561114 · ClinicalTrials.gov registry record · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
A Phase 3 study of Esophageal Stricture, sponsored by GIE Medical.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 198
- Enrollment target
- 20
- Study locations
NCT05561114: Recruiting Phase 3 study of Esophageal Stricture, sponsored by GIE Medical.
NCT05561114 is a Phase 3 study of Esophageal Stricture that is actively recruiting participants, run by GIE Medical. The registered enrollment target is 198 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05561114, a Phase 3 study of Esophageal Stricture, is actively recruiting participants, sponsored by GIE Medical.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 198 participants
- Enrollment target
- 20
- Study locations
Study Summary
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Primary Outcome
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
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
California
- University of California, Irvine - Irvine
- Gastro Care Institute - Lancaster
- Cedars Sinai - Los Angeles
- San Diego Gastroenterology - San Diego
Alabama
- Birmingham Gastroenterology Associates - Birmingham
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2031-04 |
| Phase | Phase 3 |
What NCT05561114 shows while recruiting
NCT05561114 is an interventional study that assigns participants to a tested intervention. The registered 198 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 (74% lower).
The record links to 1 condition, with Esophageal Stricture appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT05561114 names 20 study sites across 13 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05561114 about?
NCT05561114 is a clinical study titled "Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus". To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
What is the current status of trial NCT05561114?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 198 participants. The study started on 2023-12-01. Estimated completion is 2031-04.
What conditions does trial NCT05561114 study?
This clinical trial studies the following conditions: Esophageal Stricture.
What interventions are being tested in trial NCT05561114?
The interventions under investigation include: Control (OTHER), GIE Medical ProTractX3 TTS DCB (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05561114?
This trial is sponsored by GIE Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05561114 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05561114's enrollment target sits among peer trials
198 1390th of 2000 higher than 611 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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