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

NCT05870163 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2025-04-01

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Implantica CE Reflux Ltd.

    lead INDUSTRY

Principal Investigators

  • Yves Borbély, Dr. med. · Inselspital, Universitätsspital Bern

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2025-12-01
Completion
2029-12-31

Countries

  • Germany
  • Italy
  • Norway
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870163 on ClinicalTrials.gov