A Post-market Registry to Assess Safety and Performance of RefluxStop™ in the Treatment of GERD in General Hospital Practice

Launched by IMPLANTICA CE REFLUX LTD. · May 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medical device called RefluxStop™ for treating Gastroesophageal Reflux Disease (GERD), a condition where stomach acid frequently flows back into the esophagus, causing symptoms like heartburn. The trial will involve collecting information from patients who have undergone the RefluxStop™ procedure at various hospitals to see how well it works and if there are any safety concerns.

To participate in this study, individuals must be at least 18 years old and have had GERD symptoms for at least six months. They also need to be able to undergo surgery safely. After the surgery, participants will have follow-up visits at 3 and 6 months, and then annually for up to seven years to monitor their health. It’s important to note that this trial is not yet recruiting participants, but it aims to help improve treatment options for people suffering from GERD in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Willing and able to provide informed consent and to participate in the registry study;
• • 2. Age ≥ 18 years or according to local legal age of adulthood at the location of the test site if older;
• • 3. Documented GERD present for ≥ 6 months. Typical symptoms are defined as heartburn;
• • 4. 24-hour pH or impedance pH monitoring proven GERD with pH measurement, off PPI therapy for at least 7 days prior to testing. (Total distal esophageal pH must be \< 4 for ≥ 4.5% of total time during a 24-hour monitoring) and/or total reflux episodes \>55 or weekly acid \>26 for \> 5 seconds, all measured 5 cm above LES);
• • 5. Suitable to undergo general anaesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.
• Exclusion Criteria:
• • 1. Hiatal Hernia larger than 8 cm;
• • 2. Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed. Patients with substantially weak peristalsis (manometry DCI value 100-200) in esophagus measured during manometry would continue the simplified contrast swallow x-ray to perform a simplified two-hour gastric emptying contrast swallow
• • 3. History of bariatric surgery wherein the stomach fundus has been extirpated;
• • 4. Female subjects who are pregnant;
• • 5. Known sensitivity or allergies to silicone materials;
• • 6. Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry procedure (as outlined in the IFU);
• • 7. Subjects that are unable to comply with the registry requirements (for example due to major psychiatric disorder or are considered otherwise unsuitable for participation in the clinical investigation according to the investigator's judgement).