NCT05561114 Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
| NCT ID | NCT05561114 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | GIE Medical |
| Condition | Esophageal Stricture |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 22 years 2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations 3. Ogilvie Dysphagia Score of ≥2 4. Minimum esophageal lumen diameter \<13 mm 5. Willing and able to complete protocol required follow-up visits 6. Willing and able to provide written informed consent 7. Strictures ≤5cm in total length 8. Target benign esophageal stricture etiologies include: 1. Peptic stricture, 2. Schatzki's ring, 3. Stricture due to prior infection, 4. Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture 5. Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy Exclusion Criteria: 1. Two or more clinically significant (e.g. non-traversable) strictures with total length \>5cm or unable to be treated with a single balloon. 2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months 3. Contraindication to endoscopy, anesthesia or deep sedation 4