A Double Balloon Endoscopic Platform for ESD

Lumendi, LLC15 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Colon Adenoma Colon Polyp

Interventions

Double Balloon Endoluminal PlatformDEVICE

A DBA platform will be use din this registry study to facilitate ESD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Winthrop-NYU Langone

Mineola, New York, United States

Outcomes

Primary Outcomes

Ability to remove the complex polyp endoscopically

Was the lesion(s) able to be removed using the DiLumen Endolumenal Interventional Platform Device \[Yes/No\]

Time frame: Duration of Procedure

Time taken for lesion removal

Time for lesion(s) removal with the double balloon device after intervention begins

Time frame: Intervention start time until Lesion removal

Device or Procedural Adverse Events

Colon perforation, colon mucosal injury, excess bleeding will be recorded

Time frame: Up to 72 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.