Safety and Performance Study of RefluxStop Device for Treating Gastroesophageal Reflux Disease GERD in Hospital Practice

What this Trial Is About

Researchers are evaluating the safety and performance of RefluxStop2, a device used in the treatment of Gastroesophageal Reflux Disease GERD. This post-market registry study focuses on patients receiving standard care procedures to better understand how RefluxStop performs in general hospital practice. The study is sponsored by Implantica CE Reflux Ltd. and tracks outcomes over several years. Participants will be treated with either the RefluxStop device implantation using a standard surgical technique or undergo the standard of care Nissen fundoplication surgery for GERD. Both interventions are observed under typical clinical conditions. The study includes follow-up periods at 3, 6 months, and annually up to 5 years to monitor both safety and performance. During the study, participants will have regular assessments including pH monitoring and hernia evaluations. Researchers will track the position of the RefluxStop device and measure reflux symptoms using specific safety and performance endpoints at 3 and 6 months, and then yearly for up to 5 years. The total duration of participation varies, with key outcome measurements focused on the first 6 months and long-term follow-up ongoing.

Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment