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Recruiting NCT05870163

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

— Observational Gastroesophageal Reflux Disease (GERD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RefluxStop implantation, Nissen fundoplication.
Who it may be relevant to
Registry conditions: Gastroesophageal Reflux Disease (GERD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Italy, Norway, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Post-market Registry Study to Assess Safety and Performance of RefluxStop™ in the Treatment of Gastroesophageal Reflux Disease (GERD) in General Hospital Practice

Overview

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.

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

Primary outcome measures

  • Primary safety endpoint [Time frame: 6 months]
  • Primary performance endpoint [Time frame: 6 months]
Secondary outcome measures (5)
  • Secondary safety endpoint [Time frame: 3 and 6 months and annually up to 5 years]
  • Secondary performance endpoints [Time frame: 3 months and annually up to 5 years]
  • Secondary performance endpoints: RefluxStop device position [Time frame: 6 months]
  • Secondary performance endpoints: hernia assessment [Time frame: 6 months]
  • Secondary performance endpoints: pH monitoring [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Willing and able to provide informed consent and to participate in the registry study,
  • Patient's age ≥ 18 years or according to local legal age of adulthood if older,
  • Documented GERD present for > 6 months,
  • Patient has a 24-hour pH monitoring proven GERD with pH and/or impedance pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be <4 for >4.5% of time during a 24-hour monitoring and/or total reflux episodes of acid >55 or weakly acid >26 for >5 seconds at 5 cm above LES)
  • Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

Exclusion criteria

  • Presence of para-esophageal hernia or sliding hernia > 3 centimeters,
  • Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
  • History of bariatric surgery wherein the stomach fundus has been extirpated,
  • Female patients who are pregnant or nursing,
  • Known sensitivity or allergies to silicone materials,
  • Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU);
  • Patients that are unable to comply with the registry study requirements, (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the registry study according to the investigator's judgement).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 2 centers
  • Ospedale IRCCS Saverio De Bellis — Bari
  • Ospedale Buon Consiglio Fatebenefratelli — Naples
Switzerland · 2 centers
  • Inselspital, Universitätsspital Bern — Bern
  • Hirslanden Klinik — Bern
Germany · 1 center
  • Klinikum Friedrichshafen GmbH — Friedrichshafen
Norway · 1 center
  • Akershus Universitetssykehus HF — Lørenskog

Identifiers

NCT: NCT05870163 · RXI002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗