A Double Balloon Endoscopic Platform for ESD

Completed

• Conditions: Colon Polyp; Colon Adenoma
• Interventions: Device: Double Balloon Endoluminal Platform

• Registration Number: NCT03551379
• Lead Sponsor: Lumendi, LLC

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2017-09-22
• Primary Completion: 2018-03-09
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-28
• Study First Posted: 2018-06-11
• Study Completion: 2018-09-29
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-18
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic procedure	Double Balloon Endoluminal Platform	A double balloon endoscopic platform will be used during an ESD procedure

Primary Outcome Measures

Name	Time	Method
Device or Procedural Adverse Events	Up to 72 hours	Colon perforation, colon mucosal injury, excess bleeding will be recorded
Time taken for lesion removal	Intervention start time until Lesion removal	Time for lesion(s) removal with the double balloon device after intervention begins
Ability to remove the complex polyp endoscopically	Duration of Procedure	Was the lesion(s) able to be removed using the DiLumen Endolumenal Interventional Platform Device \[Yes/No\]

Trial Locations

Locations (1)

Winthrop-NYU Langone; 🇺🇸 Mineola, New York, United States