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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 is a Phase 3 study of Esophageal Stricture that is actively recruiting participants, run by GIE Medical. The registered enrollment target is 198 participants. The trial reports 20 study locations across 13 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05561114
The ClinicalTrials.gov registry entry for NCT05561114 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 198 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 Esophageal Stricture appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT05561114 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Related
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.