Trials / Recruiting
RecruitingNCT05561114
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- Sponsor
- GIE Medical · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | GIE Medical ProTractX3 TTS DCB | Paclitaxel Coated Balloon |
| OTHER | Control | Standard Endoscopic Dilation |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2026-10-01
- Completion
- 2031-04-01
- First posted
- 2022-09-30
- Last updated
- 2025-06-25
Locations
34 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05561114. Inclusion in this directory is not an endorsement.