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 range21 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:
* 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…
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.