Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis

Status: Completed
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 (DEN) with walled off pancreatic necrosis (WOPN).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: No
View:

• Subjects who are >22; inclusive of males and females.

• Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage

• Imaging suggestive of greater than or equal to 30% necrotic material

• Walled off pancreatic necrosis size ≥6 cm and ≤22cm

• Subject can tolerate repeated endoscopic procedures

• Subject capable of giving informed consent.

• Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated.

Locations
United States
Arkansas
Benjamin Tharian
Little Rock
California
Stanford University Medical Center
Palo Alto
California Pacific Medical Center - Sutter Health
San Francisco
Illinois
University of Chicago Department of Medicine
Chicago
New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick
New York
Arvin Trindade
Queens
Pennsylvania
Thomas Jefferson University
Philadelphia
Other Locations
Germany
University of Frankfurt Medicine
Frankfurt
Interdisciplinary Clinic for Endoscopy - TU Munich
München
Netherlands
Erasmus Medical Center
Rotterdam
Time Frame
Start Date: November 15, 2018
Completion Date: August 22, 2019
Participants
Target number of participants: 30
Treatments
Experimental: EndoRotor Therapy
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.
Authors
Avik Sarkar, Uzma Siddiqui, Amy Tyberg, Michel Kahaleh, Thomas Kowalski, Kenneth Binmoeller, Petros Benias, Irving Waxman, Jaroslav Zivny, Christoph Schlag, Christopher Hamerski, Christopher Chapman, Marco Bruno, Rabindra Watston, Haroon Shaheed, Arvin Trindade, Mireen Friedrich, Alexander Schlacterman, Joo Ha Hwang
Sponsors
Leads: Interscope, Inc.

This content was sourced from clinicaltrials.gov

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