RELIEF Europe Study (NCT02762487) | Clinical Trial Compass
TerminatedNot Applicable
RELIEF Europe Study
Stopped: Insufficient enrollment
Germany, Italy7 participantsStarted 2015-11
Plain-language summary
The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.
Who can participate
Age range
21 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:
* Laparoscopic sleeve gastrectomy (LSG) for obesity \>12 months prior to proposed device implantation date.
* Patient is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
* Documented pathologic esophageal acid exposure by pH monitoring per institution's standard of care (i.e. total distal ambulatory esophageal pH\< 4 for ≥ 5.3% (BRAVO) or ≥4.5% (transnasal) or abnormal DeMeester Score (\>14.72) within 12 months of proposed implantation date (After Sleeve Gastrectomy).
NOTE: SUBJECTS SHALL HAVE DISCONTINUED ALL GERD MEDICATIONS FOR AT LEAST 7 DAYS PRIOR TO TESTING WITH THE EXCEPTION OF ANTACIDS, WHICH MAY BE TAKEN UP UNTIL THE MORNING OF THE VISIT.
* Chronic GERD symptoms despite maximum medical therapy for the treatment of reflux.
* Age ≥ 21 years
* At least 30% loss of excess weight from date of original LSG surgery.
* Patient is willing and able to cooperate with follow-up examinations.
* Patient has been informed of the study procedures and the treatment and has signed an informed consent form.
Exclusion Criteria:
* Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
* Prior surgery in the area of the gastroesophageal junction (GEJ), including prior hiatal hernia repair.
* Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.
* Subject had any major complications related to the laparoscopic sleeve gastrectomy that may interfere with, or increas…
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
1
Change is GERD-HRQL Score as a measure of efficacy
Timeframe: Baseline, 6 month visit
2
Number of participants with serious complications as a measure of safety.
Timeframe: 6 month visit
3
Change is total distal acid exposure as a measure of efficacy.