NCT07004400

A Blinded Randomized Clinical Study of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of GERD

A Blinded Randomized Clinical Investigation of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of Gastroesophageal Reflux Disease (GERD).

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Implantica CE Reflux Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.

Detailed description

This study is a post-market prospective, blinded, randomized, multicenter, multi-arm clinical investigation using standard clinical procedures to record data to evaluate the safety and performance of RefluxStop™ compared with standard Nissen fundoplication for the treatment of subjects suffering from GERD. A randomization will be performed where the Subjects will be blinded as to assigned randomization group.

Conditions

• GERD (Gastroesophageal Reflux Disease)

Interventions

Type	Name	Description
DEVICE	RefluxStop™ implantation	Standard surgical technique for implantation RefluxStop™, as described in the Instructions for Use
PROCEDURE	Nissen fundoplication	Standard surgical technique for Nissen fundoplication

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

4 sites across 3 countries: Austria, Germany, Switzerland