NCT05870163 Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
| NCT ID | NCT05870163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Implantica CE Reflux Ltd. |
| Condition | Gastroesophageal Reflux Disease (GERD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2023-02-20 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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).
Contact & Investigator
Yves Borbély, Dr. med.
PRINCIPAL INVESTIGATOR
Inselspital, Universitätsspital Bern
Frequently Asked Questions
Who can join the NCT05870163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastroesophageal Reflux Disease (GERD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05870163 currently recruiting?
Yes, NCT05870163 is actively recruiting participants. Contact the research team at souheila.moutiq@implantica.com for enrollment information.
Where is the NCT05870163 trial being conducted?
This trial is being conducted at Friedrichshafen, Germany, Bari, Italy, Naples, Italy, Lørenskog, Norway and 2 additional locations.
Who is sponsoring the NCT05870163 clinical trial?
NCT05870163 is sponsored by Implantica CE Reflux Ltd.. The principal investigator is Yves Borbély, Dr. med. at Inselspital, Universitätsspital Bern. The trial plans to enroll 2,500 participants.