LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic … (NCT02429830) | Clinical Trial Compass
CompletedNot Applicable
LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy
United States30 participantsStarted 2017-04-05
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 range22 Years
SexALL
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Inclusion criteria
✓. Age \>22 years
✓. Laparoscopic sleeve gastrectomy (LSG) for obesity \>12 months prior to proposed device implantation date.
✓. Subject is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
✓. Documented typical symptoms of GERD for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastric or substernal pain which responds to acid neutralization or suppression).
✓. Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
✓. Total distal ambulatory esophageal pH must meet the following criteria: pH \<4 for \>4.5% of the time. Note: Subjects shall have discontinued any GERD medications for at least 7 days prior to testing, with the exception of antacids up to the morning of testing.
✓. Subjects with symptomatic improvement on PPI therapy demonstrated by a GERD-HRQL score of \<10 on PPI and \>15 off PPI, or subjects with a \>6 point improvement when comparing their on PPI and off PPI GERD-HRQL scores.
✓. GERD symptoms, in absence of PPI therapy (minimum 7 days).
Exclusion criteria
✕. The procedure is an emergency procedure.
✕. Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
✕. Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.
What they're measuring
1
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
Timeframe: Up to 12 Months
2
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
Timeframe: Up to 12 months
3
Percentage of Participants Reporting >=50% Reduction in Average Daily Protocol Pump Inhibitors (PPIs) Dosage Compared to Baseline at the 12-month Follow-up
Timeframe: Up to 12 months
4
Number of Participants Experiencing Serious Device and/or Procedure Related Adverse Events After LINX Placement Out to 12 Months
✕. Subject had any major complications related to the laparoscopic sleeve gastrectomy that may interfere with, or increase the risks of the LINX procedure (such as, but not limited to, leaks from the gastric remnant and infection at the sleeve gastrectomy)
✕. Plans to surgically revise the gastric pouch (either known preoperatively or decided intraoperatively)
✕. Currently being treated with another investigational drug or investigational device.
✕. Suspected or confirmed esophageal or gastric cancer or prior gastric or esophageal surgery or endoscopic intervention for GERD (with the exception of sleeve gastrectomy).
✕. Distal amplitude \<35 mmHg or \<70% peristaltic sequences (if using Conventional Manometry). -or- If using High Resolution Manometry (exclude for any of the following):