EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

Status Completed

Clinical Trial Summary

Clinical Trial Description

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). Total enrollment 30 subjects with at least 15 enrolled in the US. Subjects will be debrided with the EndoRotor either at the time of stent placement or post placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of 2 days is required between each EndoRotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor debridement procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03694210
Study type	Interventional
Source	Interscope, Inc.
Contact
Status	Completed
Phase	N/A
Start date	November 15, 2018
Completion date	August 22, 2019

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