Registry Evaluation of a Double Balloon Accessory Device

Status unconfirmed

Conditions studied: Adenomatous Polyp of Colon

In brief

This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.

Key facts

Study ID

NCT03942965

Run by

Lumendi, LLC

People needed

165

Starts

2019-01-22

Expected to finish

2021-03-31

Last updated by the study team

2020-12-11

Who can join

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

You may qualify if…

• Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
• Patients capable of giving informed consent in English
• No medical contraindication to endoscopic mucosal resection or endoscopic submucosal disection

You may not qualify if…

• No patients less than 18 years of age.
• Any contraindication to colonoscopy with due to subject's colon anatomy (i.e. stricture)
• History of open or laparoscopic colorectal surgery
• History of Inflammatory Bowel Disease

Where it is running

• University of Florida - Division of Gastroenterology, Hepatology and Nutrition — Gainesville, Florida, United States
• Geisinger Health System — Danville, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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