RecruitingNCT05870163

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

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


Sponsor

Implantica CE Reflux Ltd.

Enrollment

2,500 participants

Start Date

Feb 20, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Nissen fundoplication and a medical device called RefluxStop implantation for people with gastroesophageal reflux disease (gerd). The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERefluxStop implantation

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

PROCEDURENissen 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

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NCT05870163


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