NCT05870163View on ClinicalTrials.gov

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

RecruitingOBSERVATIONAL
Enrollment

2,500

Participants

Timeline

Start Date

February 20, 2023

Primary Completion Date

December 1, 2025

Study Completion Date

December 31, 2029

Conditions
Gastroesophageal Reflux Disease (GERD)
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

Trial Locations (6)

1478

RECRUITING

Akershus Universitetssykehus HF, Lørenskog

3010

RECRUITING

Inselspital, Universitätsspital Bern, Bern

3013

RECRUITING

Hirslanden Klinik, Bern

70013

RECRUITING

Ospedale IRCCS Saverio De Bellis, Bari

80123

RECRUITING

Ospedale Buon Consiglio Fatebenefratelli, Napoli

88048

ACTIVE_NOT_RECRUITING

Klinikum Friedrichshafen GmbH, Friedrichshafen

All Listed Sponsors
lead

Implantica CE Reflux Ltd.

INDUSTRY