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EndoRotor® Endoscopic Mucosal Resection System for the Colon

NCT04203667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-04-05

Study results available
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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.

Conditions

  • Polyp of Colon
  • Endoscopic Mucosal Resection
  • Recurrent Colon Adenoma

Interventions

DEVICE

EndoRotor Resection

The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.

Sponsors & Collaborators

  • Interscope, Inc.

    lead INDUSTRY

Principal Investigators

  • Guido Costamagna, MD · Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2020-04-05
Completion
2020-04-05
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Italy

Study Locations

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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 NCT04203667 on ClinicalTrials.gov