Clinical Trial TitlePATENT-E: Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture-Esophagus
National Clinical Trial Number:NCT05561114
Clinical Trial Protocol Description:
This is a randomized, single-blind, clinical trial to evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures in patients who are experiencing recurrent benign esophageal stricture. A description of this clinical trial will be available at www.ClinicalTrials.gov, as required by U.S. law.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 22 years of age or older.
- Have been diagnosed with a benign esophageal stricture with at least 2 previous dilations to at least 14mm within the last 12 months.
- Have an Ogilvie Dysphagia Score of ≥2.
- Have a minimum esophageal lumen diameter <13mm.
You will be excluded from the study if any of the following criteria apply to you:
- Have two or more clinically significant (e.g. non-traversable) strictures with total length >5cm or unable to be treated with a single balloon.
- Have contraindication to endoscopy, anesthesia or deep sedation.
- Have a benign esophageal stricture due to extrinsic esophageal compression, caustic ingestion, and purely radiation induced strictures (e.g. post head/neck cancer treatment).
- Have a history of diagnosis of eosinophilic esophagitis (EoE).
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.