Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
Recruiting
Phase 3
Interventional Study
Esophageal Stricture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 198 (estimated)
- Sponsor
- GIE Medical · Industry
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About This Trial
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Trial Locations
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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 writ…
Contacts