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.
Study Type
OBSERVATIONAL
Enrollment
2,500
Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use
Standard of care Nissen fundoplication surgery
Klinikum Friedrichshafen GmbH
Friedrichshafen, Germany
ACTIVE_NOT_RECRUITINGOspedale IRCCS Saverio De Bellis
Bari, Italy
RECRUITINGOspedale Buon Consiglio Fatebenefratelli
Naples, Italy
Primary safety endpoint
Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs)
Time frame: 6 months
Primary performance endpoint
Assessment of GERD symptoms, measured by GERD Health-Related Quality of Life (HRQL) score (questions 1-10). (An answer of zero means no symptoms)
Time frame: 6 months
Secondary safety endpoint
Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs) at 3 months and annually up to 5 years. Plus Incidence of Adverse Device Effects (ADEs) and procedure related or unknown Adverse Events (AEs) at 3 and 6 months and annually up to 5 years
Time frame: 3 and 6 months and annually up to 5 years
Secondary performance endpoints
Assessment of GERD symptoms, assessed by GERD-HRQL score (questions 1-10)
Time frame: 3 months and annually up to 5 years
Secondary performance endpoints: RefluxStop device position
Location and function of the device evaluated by a simplified contrast swallow x-ray with overview pictures of device
Time frame: 6 months
Secondary performance endpoints: hernia assessment
Location of baseline hernia or any new hernia by a simplified contrast swallow x-ray picture
Time frame: 6 months
Secondary performance endpoints: pH monitoring
Reduction or normalisation from baseline of the total acid (pH\<4) exposure time during 24-hour pH monitoring
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Akershus Universitetssykehus HF
Lørenskog, Norway
RECRUITINGInselspital, Universitätsspital Bern
Bern, Switzerland
RECRUITINGHirslanden Klinik
Bern, Switzerland
RECRUITINGTime frame: 6 months