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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Device: RefluxStop implantation
* Procedure: Nissen fundoplication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide informed consent and to participate in the registry study, Patient's age ≥ 18 years or according to local legal age of adulthood if older, Documented GERD present for > 6 months, 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) Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator. Exclusion criteria: Presence of para-esophageal hernia or sliding hernia > 3 centimeters, Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed, History of bariatric surgery wherein the stomach fundus has been extirpated, Female patients who are pregnant or nursing, Known sensitivity or allergies to silicone materials, Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU); 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RefluxStop patients<br> | Device: RefluxStop implantation<br>* Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use<br>|
| Nissen fundoplication patients<br> | Procedure: Nissen fundoplication<br>* Standard of care Nissen fundoplication surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary safety endpoint | Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs) | 6 months | 
| Primary performance endpoint | Assessment of GERD symptoms, measured by GERD Health-Related Quality of Life (HRQL) score (questions 1-10). (An answer of zero means no symptoms) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary safety endpoint | Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs) at 3 months and annually up to 5 years. Plus Incidence of Adverse Device Effects (ADEs) and procedure related or unknown Adverse Events (AEs) at 3 and 6 months and annually up to 5 years | 3 and 6 months and annually up to 5 years | 
| Secondary performance endpoints | Assessment of GERD symptoms, assessed by GERD-HRQL score (questions 1-10) | 3 months and annually up to 5 years | 
| Secondary performance endpoints: RefluxStop device position | Location and function of the device evaluated by a simplified contrast swallow x-ray with overview pictures of device | 6 months | 
| Secondary performance endpoints: hernia assessment | Location of baseline hernia or any new hernia by a simplified contrast swallow x-ray picture | 6 months | 
| Secondary performance endpoints: pH monitoring | Reduction or normalisation from baseline of the total acid (pH<4) exposure time during 24-hour pH monitoring | 6 months |