Torax Medical Inc. has partnered with selected medical centers in the United States to evaluate the safety and efficacy of the LINX device in patients with gastroesophageal reflux disease (GERD) who have undergone a previous laparoscopic sleeve gastrectomy (LSG) for obesity and are looking for an alternative to taking daily proton pump inhibitors (PPIs) or other anti-reflux medications. The purpose of the study is to see whether the LINX device can be used safely in people with GERD who have had LSG surgery and if it can reduce or eliminate GERD-related symptoms.
To qualify, patients must be at least 22 years old, had bariatric sleeve surgery at least 12 months ago, have documented symptoms of GERD (acid reflux), currently need to take daily GERD medication and meet other criteria. Participation in the clinical trial will last 1 years after the LINX device is implanted.
Note: The LINX device has not been proven safe and effective in patients who have undergone LSG surgery which is the purpose of this research. As a result, there are both known and potentially unknown risks associated with LINX surgery for people who have had LSG surgery.
More information can be found on the National Institute of Health, clinicaltrials.gov website: https://clinicaltrials.gov/ct2/show/NCT02429830?term=TORAX+RELIEF&cond=GERD&rank=1
CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use. The LINX device is approved in the US to be used for patients who have never had gastric (stomach) surgery.