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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
The LINX device is a permanent implant placed at the area of the lower esophageal sphincter (LES) and is designed to augment a weak LES and minimize or eliminate GERD-related symptoms.
Schön Klinik Nürnberg
Fürth, Germany
EvK Herne
Herne, Germany
Uni Klinik Leipzig
Leipzig, Germany
Policlinico San Donato
Milan, Italy
Change is GERD-HRQL Score as a measure of efficacy
Time frame: Baseline, 6 month visit
Number of participants with serious complications as a measure of safety.
Time frame: 6 month visit
Change is total distal acid exposure as a measure of efficacy.
Time frame: Baseline, 6 month visit
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