A Double Balloon Endoscopic Platform for ESD

Status Completed

Clinical Trial Summary

The purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy.

Clinical Trial Description

Endoscopic removal of Complex colon polyps (benign polyps >=2cm) is a technically challenging procedure. Complex benign polyps have a greater chance of becoming cancerous if not removed.

The DiLumen™ Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope to stabilize it in the large intestine, and facilitates use of the endoscope for optical visualization, diagnosis, and treatment. The device is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis, and endoscopic treatment.

The device received 510k clearance on Dec 6, 2016. The study will evaluate performance of the device during routine, scheduled, endoscopic polyp removal for these large polyps. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03551379
Study type	Observational
Source	Lumendi, LLC
Contact
Status	Completed
Phase
Start date	September 22, 2017
Completion date	September 29, 2018

View Details

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