Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05870163

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

Sponsor: Implantica CE Reflux Ltd.

View on ClinicalTrials.gov

Summary

This post-market registry aims to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in standard of care procedures.

Official title: A Post-market Registry Study to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2500

Start Date

2023-02-20

Completion Date

2029-12-31

Last Updated

2025-04-01

Healthy Volunteers

No

Interventions

DEVICE

RefluxStop implantation

Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use

PROCEDURE

Nissen fundoplication

Standard of care Nissen fundoplication surgery

Locations (6)

Klinikum Friedrichshafen GmbH

Friedrichshafen, Germany

Ospedale IRCCS Saverio De Bellis

Bari, Italy

Ospedale Buon Consiglio Fatebenefratelli

Naples, Italy

Akershus Universitetssykehus HF

Lørenskog, Norway

Inselspital, Universitätsspital Bern

Bern, Switzerland

Hirslanden Klinik

Bern, Switzerland