Registry to evaluate RefluxStop for treating GERD

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

This study is testing the RefluxStop device to see if it safely helps people with GERD feel better compared to standard treatments.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Implantica CE Reflux Ltd. (Industry-sponsored)
• Locations: 6 sites (Friedrichshafen and 5 other locations)
• Trial ID: NCT05870163 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with documented GERD lasting more than 6 months and suitable for laparoscopic surgery.

Not a fit: Patients with specific contraindications such as para-esophageal hernias or a history of bariatric surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of RefluxStop, potentially improving treatment options for GERD patients.

How similar studies have performed: While this registry focuses on a specific device, similar observational studies have shown promise in evaluating new treatments for GERD.

Eligibility criteria

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 this trial is running

Friedrichshafen and 5 other locations

• Klinikum Friedrichshafen GmbH — Friedrichshafen, Germany (Active_not_recruiting)
• 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)

Study contacts

• Principal investigator: Yves Borbély, Dr. med. — Inselspital, Universitätsspital Bern
• Study coordinator: Souheila Moutiq

Conditions Gastroesophageal Reflux Disease