A Double Balloon Endoscopic Platform for ESD

Lumendi

Status: Completed

Conditions: Colon Adenoma; Colon Polyp

Treatments: Device: Double Balloon Endoluminal Platform

Study type: Observational

Funder types: Industry

Identifiers

NCT03551379

DD-017

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects > 18 years of age
• Subjects scheduled for endoscopic removal of suspected complex adenomatous polyps in the large intestine which are sessile or polypoid lesions ≥ 2cm, near the ileocecal valve, dentate line, over a fold, or at a flexure; and or lesions tethered to the colon wall due to previous incomplete resection
• Subjects willing and able to give informed consent
• Subjects who in the opinion of the Principal Investigator have no medical contraindication to endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)

Exclusion criteria

• Subjects with a contraindication to colonoscopy, including but not limited to active colitis, perforation, or stricture.
• Subjects with a history of open or laparoscopic colorectal surgery
• Subjects with a history of Inflammatory Bowel Disease (IBD)
• Subjects with a suspected malignancy on polyp assessment

Trial design

15 participants in 1 patient group

Endoscopic procedure

Description:

A double balloon endoscopic platform will be used during an ESD procedure

Treatment:

Device: Double Balloon Endoluminal Platform