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Evaluation of Safety and Effectiveness of the RefluxStop Device in the Management of GERD

NCT02759094 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-04-06

No results posted yet for this study

Summary

Prospective, open-label, multi-centre, single arm treatment only trial to evaluate the safety and effectiveness of RefluxStop for the treatment of GERD.

The used medical device "RefluxStop" is an implantable single use sterile device to ensure maintenance of gastro oesophageal junction (GEJ) in an intra-abdominal position to reduce or eliminate GERD.

Conditions

  • GERD

Interventions

DEVICE

Treatment with RefluxStop

A standard laparoscopic approach will be used to reposition the lower oesophageal sphincter (LES) to its intra-abdominal position. The RefluxStop device will be then positioned and fixed in the gastric funds to ensure intra-abdominal positioning of the GEJ (Gastro-oesophageal Junction) at all time. After confirming proper placement, the laparoscopic implant procedure will be completed and access points will be closed.

Sponsors & Collaborators

  • Implantica CE Reflux Ltd.

    lead INDUSTRY

Principal Investigators

  • László Harsányi, Prof. · Semmelweis University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-03-31
Completion
2023-12-31

Countries

  • Hungary
  • Serbia

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 NCT02759094 on ClinicalTrials.gov