UnknownNot Applicable

Registry Evaluation of a Double Balloon Accessory Device

United States165 participantsStarted 2019-01-22

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Ability to perform the procedure safely and effectively with the study device.

Timeframe: Intraoperatively

Trial details

NCT IDNCT03942965

SponsorLumendi, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Adenomatous Polyp of Colon trials