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Clinical Trial Summary

POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.


Clinical Trial Description

The study is designed to determine the safety and effectiveness for drug coated balloon (DCB) for treating intestinal strictures. Up to 15 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03886324
Study type Interventional
Source GIE Medical
Contact
Status Active, not recruiting
Phase N/A
Start date February 25, 2019
Completion date December 2025

See also
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