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

Launched by IMPLANTICA CE REFLUX LTD. · May 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a device called RefluxStop™ for treating Gastroesophageal Reflux Disease (GERD), a condition where stomach acid frequently flows back into the esophagus, causing discomfort. The trial is currently looking for participants aged 18 and older who have been diagnosed with GERD for at least six months. To qualify, potential participants must also have had a specific test showing their GERD is significant.

If you join this study, you will be monitored closely to see how well the RefluxStop™ device works in standard treatment procedures. It's important to note that certain individuals, such as those with specific types of hernias, pregnant or nursing women, and those with certain medical conditions, may not be eligible to participate. This trial aims to gather valuable information that could help improve treatment options for 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. 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).