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Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
Sponsor: Implantica CE Reflux Ltd.
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
Conditions
Interventions
RefluxStop implantation
Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use
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