CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
EndoRotor Therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03694210
NCT03694210N/ACompleted

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

Interscope, Inc.·interventional·Posted Oct 3, 2018·Updated Nov 2, 2021

In Brief

A clinical study evaluating EndoRotor Therapy for Acute Pancreatic Necrosis and 2 related conditions. Completed, enrolled 30 participants across 10 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Netherlands, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 3, 2018
Enrollment StartNov 15, 2018
Primary CompletionAug 22, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.7 years ago

Interventions

EndoRotor Therapydevice

To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.