Trial Details
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
NCT05561114
RECRUITING
DESCRIPTION
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
CONDITIONS
Esophageal Stricture
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
