LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy
- Conditions
- GERDGastroesophageal Reflux Disease
- Interventions
- Device: LINX device
- Registration Number
- NCT02429830
- Lead Sponsor
- Torax Medical Incorporated
- Brief 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.
- Detailed Description
The objective of this study is to confirm safety and efficacy after laparoscopic sleeve gastrectomy (LSG) in subjects indicated for LINX is similar to the outcomes that formed the basis for the LINX Premarket Approval to support modification of the current labeling. Presently, there is a precautionary statement that safety and effectiveness of the LINX has not been established for prior esophageal or gastric surgery or endoscopic intervention.
Patients with GERD that have undergone a LSG procedure have limited surgical treatment options if they are looking for an alternative to continuous acid suppression therapy (i.e. proton pump inhibitors or equivalent). One procedure, fundoplication, is extremely difficult to perform as LSG patients have a limited amount of fundus tissue remaining after sleeve surgery. Roux-en-Y gastric bypass (RYGB) may be chosen as a conversion procedure but is more invasive with the potential for serious complications. LINX may be considered as an alternative and less invasive option that may potentially have few complications compared to RYGB.
The study is an observational, multicenter, single-arm study with prospective enrollment. Based on the observational status of the study, no formal statistical hypothesis tests will be conducted. Up to 30 patients meeting the eligibility requirements will be implanted with LINX and followed through 12-months after implant. Up to twelve (12) clinical sites will enroll subjects. Safety evaluations will be ongoing throughout the duration of the study, starting at the implant procedure. Efficacy endpoints will be evaluated at the 12-month visit.
Safety will be evaluated based on the rate of serious device and procedure related adverse events (AEs). Safety will also be evaluated by endoscopy to assess the mucosa and x-rays to verify device location at 12 months post implant. Efficacy will be measured at 12 months (compared to baseline) by examining 3 variables: normalization of total distal acid exposure or at least a 50% reduction, at least a 50% reduction in total GERD-HRQL scores and at least a 50% reduction in average daily PPI dosage.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm study LINX device Previous LSG patient will be treated with the LINX device and serve as their own control
- Primary Outcome Measures
Name Time Method Percentage of Participants Reporting Greater Than or Equal to (>=) 50 Percent (%) Reduction in Total Gastroesophageal Reflux Disease (GERD)- Health-Related Quality of Life (HRQL) Score Compared to Baseline (Off GERD Medications) at the 12-month Follow-up Up to 12 Months Percentage of participants reporting \>=50% reduction in total GERD-HRQL score compared to baseline (off GERD Medications) at the 12-month follow-up were reported. The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating, unable to do activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score was 50 (incapacitated in all questions).
Percentage of Participants Reporting Normalization of Total Distal Acid Exposure Time or at Least a 50% Reduction in Total Distal Acid Exposure Time Compared to Baseline at the 12-month Follow-up Up to 12 months Percentage of participants reporting normalization of total distal acid exposure time or at least a 50% reduction in total distal acid at the 12-month follow-up were reported. The testing was performed by a reflux sensing implantable capsule (for example, Bravo) or via a trans-nasal catheter. Success of the LINX device in decreasing abnormal levels of gastric acid in the esophagus was defined as normalization of distal acid exposure time (pH less than \[\<\] 4 for greater than or equal to \[\>=\] 4.5% of monitoring time) or at least 50% reduction in distal acid exposure time compared to baseline.
Percentage of Participants Reporting >=50% Reduction in Average Daily Protocol Pump Inhibitors (PPIs) Dosage Compared to Baseline at the 12-month Follow-up Up to 12 months Percentage of participants reporting \>=50% reduction in average daily protocol pump inhibitors (PPIs) dosage compared to baseline at the 12-month follow-up were reported.
Number of Participants Experiencing Serious Device and/or Procedure Related Adverse Events After LINX Placement Out to 12 Months Up to 12 months Number of participants experiencing serious device and/or procedure related adverse events after LINX placement out to 12 months were reported. SAE is any AE that results in: requires subject hospitalization greater than (\>) 24 hours; is life-threatening or results in death; requires prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; results in fetal distress, fetal death, or a congenital anomaly or birth defect; requires intervention to prevent permanent impairment or damage of body function or structure; other serious important medical events that do not fit in the other outcomes and may jeopardize the participant and may require medical or surgical intervention to prevent one of the other outcomes.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
RWJBH Univ. Hospital Somerset/Advanced Surgical and Bariatrics of NJ, PA
🇺🇸Somerset, New Jersey, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Gunderson Health System
🇺🇸La Crosse, Wisconsin, United States
Mercy Health Northwest Arkansas
🇺🇸Rogers, Arkansas, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Northwest Allied Bariatric & Foregut Surgery
🇺🇸Tucson, Arizona, United States
Institute of Esophageal and Reflux Surgery
🇺🇸Englewood, Colorado, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
Adirondack Surgical Group
🇺🇸Saranac Lake, New York, United States
Coastal Carolina Bariatric & Surgical Center
🇺🇸Summerville, South Carolina, United States
Panhandle Weight Loss Center
🇺🇸Amarillo, Texas, United States