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A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice

NCT07004439 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-06-04

No results posted yet for this study

Summary

A post-market retrospective and prospective, open label, multicenter, single-arm registry study using standard clinical procedures to record available and/or new data to evaluate the safety and performance of RefluxStop™ for the treatment of subjects suffering from GERD.

Following surgery, patients will have follow-ups visits at 3 and 6 months and annually up to 7 years.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DEVICE

RefluxStop™ implantation

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

Sponsors & Collaborators

  • Implantica CE Reflux Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2029-08-01
Completion
2035-08-01

Countries

  • Germany
  • Spain

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 NCT07004439 on ClinicalTrials.gov