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EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

NCT03694210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-02

Study results available
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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).

Conditions

Interventions

DEVICE

EndoRotor Therapy

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

Sponsors & Collaborators

  • Interscope, Inc.

    lead INDUSTRY

Principal Investigators

  • Marco Bruno, MD PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2019-08-22
Completion
2019-08-22
FDA Device
Yes

Countries

  • United States
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694210 on ClinicalTrials.gov