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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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