Registry to evaluate RefluxStop for treating GERD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to assess the safety and performance of the RefluxStop™ device in treating Gastroesophageal Reflux Disease (GERD) as part of standard care procedures. Participants will undergo a thorough evaluation, including 24-hour pH monitoring to confirm GERD diagnosis before receiving the RefluxStop implantation or Nissen fundoplication. The study will collect data on patient outcomes and device performance over time to ensure effective treatment options for GERD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to provide informed consent and to participate in the registry study,
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 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)
5. Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.

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 could be 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 in unfavorable conduct of the registry study procedure (as outlined in the IFU);
7. 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).

Where it's running

• Ospedale IRCCS Saverio De Bellis
  Bari, Italy Recruiting
• Ospedale Buon Consiglio Fatebenefratelli
  Naples, Italy Recruiting
• Akershus Universitetssykehus HF
  Lørenskog, Norway Recruiting
• Inselspital, Universitätsspital Bern
  Bern, Switzerland Recruiting
• Hirslanden Klinik
  Bern, Switzerland Recruiting
• Klinikum Friedrichshafen GmbH
  Friedrichshafen, Germany Active not recruiting

Study contacts

• Principal investigator: Yves Borbély, Dr. med. — Inselspital, Universitätsspital Bern
• Study coordinator: Souheila Moutiq
• Email: souheila.moutiq@implantica.com
• Phone: +41 78 249 77 28

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.