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A Blinded Randomized Clinical Study of RefluxStop™ Compared With Nissen Fundoplication in the Treatment of GERD

NCT07004400 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-04

No results posted yet for this study

Summary

This study will evaluate if the RefluxStop™ device will treat your acid reflux and improve your symptoms and how it compares to the standard surgical treatment for GERD, the Nissen fundoplication.

Conditions

  • GERD (Gastroesophageal Reflux Disease)

Interventions

DEVICE

RefluxStop™ implantation

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

PROCEDURE

Nissen fundoplication

Standard surgical technique for Nissen fundoplication

Sponsors & Collaborators

  • Implantica CE Reflux Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • Austria
  • Germany
  • 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 NCT07004400 on ClinicalTrials.gov