Acid Reflux Management with the RefluxStop Implant: A Prospective Multicenter Trial with 3-Year Outcomes

Area of Science:

• Gastroenterology
• Surgical Innovation
• Medical Device Technology

Background:

• Gastroesophageal reflux disease (GERD) affects many individuals, often managed with conventional surgeries that carry risks of adverse events.
• RefluxStop is a novel implant designed for laparoscopic GERD treatment, aiming to restore gastroesophageal junction function without encircling the esophagus.

Purpose of the Study:

• To evaluate the 3-year safety and effectiveness of the RefluxStop implant in patients with chronic GERD.
• To assess the impact of RefluxStop on quality of life, medication usage, and specific GERD symptoms.

Main Methods:

• A prospective, single-arm, multicentric clinical trial was conducted.
• Fifty patients with chronic GERD were treated with the RefluxStop implant.
• Follow-up was conducted over three years, analyzing safety and effectiveness data.

Main Results:

• No device-related adverse events, erosion, migration, or explantation occurred in 47 patients over 3 years.
• Significant improvements were observed: 93.1% reduction in GERD-HRQL score, 97.9% reduction in daily regurgitation, and complete resolution of baseline odynophagia.
• No patients required regular daily proton pump inhibitor (PPI) therapy at 3-year follow-up; 98% experienced improvement in dysphagia.

Conclusions:

• RefluxStop surgery is a safe and effective treatment for GERD, avoiding esophageal encirclement and pressure.
• The implant demonstrates substantial improvements in patient quality of life, evidenced by high GERD-HRQL score reduction and elimination of PPI dependency.
• Long-term follow-up confirms the device's efficacy in managing GERD symptoms, including regurgitation and dysphagia.