TerminatedNot Applicable

Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)

United States10 participantsStarted 2011-06

Plain-language summary

The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device.

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: * Subject is 18 years of age or older. * Typical symptoms of heartburn and/or regurgitation requiring daily PPI therapy. * Subject agrees to participate and signs consent form. Exclusion Criteria: * Patient is pregnant. * Patient has a hiatal hernia greater than 2cm. * Presence of persistent daily solid food dysphagia, unplanned weight loss over ten pounds, esophageal bleeding, or vomiting more than once per week). * Active medical condition that would preclude the subject from finishing this study. * BMI \> 39.

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

Reduction of reflux symptoms measured by GERD HRQL

Timeframe: 6 months

Trial details

NCT IDNCT01199679

SponsorCook Group Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease trials