A Double Balloon Endoscopic Platform for ESD

Completed

Conditions studied: Colon Adenoma, Colon Polyp

In brief

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

Key facts

Study ID

NCT03551379

Run by

Lumendi, LLC

People needed

15

Starts

2017-09-22

Expected to finish

2018-09-29

Last updated by the study team

2019-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Winthrop-NYU Langone — Mineola, New York, United States

Full record on ClinicalTrials.gov

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