Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
GIE Medical
Summary
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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), in…
Interventions
- Combination ProductGIE Medical ProTractX3 TTS DCB
Paclitaxel Coated Balloon
- OtherControl
Standard Endoscopic Dilation
Locations (34)
- Birmingham Gastroenterology AssociatesBirmingham, Alabama
- Honor HealthScottsdale, Arizona
- University of California, IrvineIrvine, California
- Gastro Care InstituteLancaster, California
- Cedars SinaiLos Angeles, California
- San Diego GastroenterologySan Diego, California