NCT07004400View on ClinicalTrials.gov

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

NANot yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

Conditions
GERD (Gastroesophageal Reflux Disease)
Interventions
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

Trial Locations (4)

Unknown

Universitätsklinik für Allgemeinchirurgie Klinische Abteilung für Viszeralchirurgie, Vienna

St. Elisabethen Krankenhaus Frankfurt, Frankfurt

Klinikum Friedrichshafen GmbH, Friedrichshafen

Klinik Beau-Site Hirslanden Bern, Bern

All Listed Sponsors
lead

Implantica CE Reflux Ltd.

INDUSTRY