EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial
Completed · Not applicable
Conditions studied: Acute Pancreatic Necrosis, Acute Pancreatitis, Necrotizing Pancreatitis
In brief
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).
Key facts
- Study ID
- NCT03694210
- Run by
- Interscope, Inc.
- People needed
- 30
- Starts
- 2018-11-15
- Expected to finish
- 2019-08-22
- Last updated by the study team
- 2021-11-02
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Subject unable to give informed consent.
- Subject is unwilling to return for repeated endoscopies.
- Documented Pseudoaneurysm > 1cm within the WOPN
- Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound).
- Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
- Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance).
- Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
- Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.
Where it is running
- Benjamin Tharian — Little Rock, Arkansas, United States
- Stanford University Medical Center — Palo Alto, California, United States
- California Pacific Medical Center - Sutter Health — San Francisco, California, United States
- University of Chicago Department of Medicine — Chicago, Illinois, United States
- Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
- Arvin Trindade — Queens, New York, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- University of Frankfurt Medicine — Frankfurt, Germany
- Interdisciplinary Clinic for Endoscopy - TU Munich — München, Germany
- Erasmus Medical Center — Rotterdam, Netherlands
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.