Esophageal Stricture Clinical Trial
Official title:
Gastrointestinal Drug-Coated Balloon for the Treatment of Symptomatic Recurrent Benign Esophageal Stricture
INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
The study is designed to determine the safety and effectiveness of drug coated balloon (DCB) treatments on esophageal stricture. Up to 30 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional. ;
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