Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures.
• Age ≥ 22 years
• Diagnosis of a benign esophageal stricture with at least 2 previous dilations
• Ogilvie Dysphagia Score of ≥2
• Minimum esophageal lumen diameter \<13 mm
• Willing and able to complete protocol required follow-up visits
• Willing and able to provide written informed consent
• Strictures ≤5cm in total length
• Target benign esophageal stricture etiologies include:
‣ Peptic stricture,
⁃ Schatzki's ring,
⁃ Stricture due to prior infection,
⁃ Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture
⁃ Post surgical (e.g. anastomotic), including post curative esophagectomy with or without prior neoadjuvant chemoradiation therapy