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

Last updated: March 26, 2025
Sponsor: Implantica CE Reflux Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Non-ulcer Dyspepsia (Nud)

Treatment

Nissen fundoplication

RefluxStop implantation

Clinical Study ID

NCT05870163
RXI002
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Willing and able to provide informed consent and to participate in the registrystudy,

  2. Patient's age ≥ 18 years or according to local legal age of adulthood if older,

  3. Documented GERD present for > 6 months,

  4. Patient has a 24-hour pH monitoring proven GERD with pH and/or impedance pHmeasurement, off PPI therapy for at least 7 days prior to testing. (Total distalesophageal pH must be <4 for >4.5% of time during a 24-hour monitoring and/or totalreflux episodes of acid >55 or weakly acid >26 for >5 seconds at 5 cm above LES)

  5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgerycandidate as determined by the investigator.

Exclusion

Exclusion criteria:

  1. Presence of para-esophageal hernia or sliding hernia > 3 centimeters,

  2. Known presence of delayed gastric emptying, if no other cause for acid reflux couldbe diagnosed,

  3. History of bariatric surgery wherein the stomach fundus has been extirpated,

  4. Female patients who are pregnant or nursing,

  5. Known sensitivity or allergies to silicone materials,

  6. Intraoperative findings determined by the investigator that may result inunfavorable conduct of the registry study procedure (as outlined in the IFU);

  7. Patients that are unable to comply with the registry study requirements, (forexample due to major psychiatric disorder or are considered otherwise unsuitable forparticipation in the registry study according to the investigator's judgement).

Study Design

Total Participants: 2500
Treatment Group(s): 2
Primary Treatment: Nissen fundoplication
Phase:
Study Start date:
February 20, 2023
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Klinikum Friedrichshafen GmbH

    Friedrichshafen, 88048
    Germany

    Site Not Available

  • Mathilden Hospital

    Herford, 32052
    Germany

    Site Not Available

  • Ospedale IRCCS Saverio De Bellis

    Bari, 70013
    Italy

    Active - Recruiting

  • Ospedale Buon Consiglio Fatebenefratelli

    Napoli, 80123
    Italy

    Active - Recruiting

  • Akershus Universitetssykehus HF

    Lørenskog, 1478
    Norway

    Active - Recruiting

  • Hirslanden Klinik

    Bern, 3013
    Switzerland

    Active - Recruiting

  • Inselspital, Universitätsspital Bern

    Bern, 3010
    Switzerland

    Active - Recruiting

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