Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon

Status: Completed
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR. In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: No
View:

• Subjects aged ≥18 to ≤85 years.

• At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length.

• Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia.

• Favorable anatomy that allows the investigator to access the lesion.

• Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit.

• Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.

Locations
United States
Pennsylvania
Geisinger Medical Center
Danville
Other Locations
France
Centre Hospitalier Universitaire (CHU)
Angers
Hopital Edouard Herriot
Lyon
Cochin University Hospital
Paris
Germany
Allgemeines Krankenhaus Celle
Celle
Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf
Hamburg
Catholic Clinic Mainz
Mainz
Sana Klinikum Offenbach
Offenbach
Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica
Rome
Humanitas Research Hospital & Humanitas University
Rozzano
Time Frame
Start Date: April 18, 2018
Completion Date: April 5, 2020
Participants
Target number of participants: 66
Treatments
Other: EndoRotor Resection Arm
All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection.
Sponsors
Leads: Interscope, Inc.

This content was sourced from clinicaltrials.gov