Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| RefluxStop patients
|
Device: RefluxStop implantation
Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use
|
| Nissen fundoplication patients
|
Procedure: Nissen fundoplication
Standard of care Nissen fundoplication surgery
|
Outcome Measures
Primary Outcome Measures
- Primary safety endpoint [6 months]
Incidence of Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs) and Device Deficiencies (DDs)
- Primary performance endpoint [6 months]
Assessment of GERD symptoms, measured by GERD Health-Related Quality of Life (HRQL) score (questions 1-10). (An answer of zero means no symptoms)
Secondary Outcome Measures
- Secondary safety endpoint [3 and 6 months and annually up to 5 years]
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
- Secondary performance endpoints [3 months and annually up to 5 years]
Assessment of GERD symptoms, assessed by GERD-HRQL score (questions 1-10)
- Secondary performance endpoints: RefluxStop device position [6 months]
Location and function of the device evaluated by a simplified contrast swallow x-ray with overview pictures of device
- Secondary performance endpoints: hernia assessment [6 months]
Location of baseline hernia or any new hernia by a simplified contrast swallow x-ray picture
- Secondary performance endpoints: pH monitoring [6 months]
Reduction or normalisation from baseline of the total acid (pH<4) exposure time during 24-hour pH monitoring
Other Outcome Measures
- Exploratory endpoints: Patient Reported Outcomes - Quality of life questionnaire [3 and 6 months and annually up to 5 years]
EQ-5D (Euro Quality of life-5 Dimension) questionnaire: measure of quality of life with one question for each of the five dimensions that are mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, the patients assess if they have no problem, slight, moderate, severe or extreme problems.
- Exploratory endpoints: Patient Reported Outcomes - Work related questionnaire [3 and 6 months and annually up to 5 years]
WPAI (work related productivity gains): 5 questions to assess how health problems effect the patient work Score 0 to 10. Zero meaning health problems have no effect on work
- Exploratory endpoints: Health economic outcomes - Visit to General Practitioner [3 and 6 months and annually up to 5 years]
Evaluation of number of visit to the General Practitioner
- Exploratory endpoints: Health economic outcomes - PPI treatment use [3 and 6 months and annually up to 5 years]
Counting of the number of patients using PPI (Proton Pump Inhibitors)
- Exploratory endpoints: Health economic outcomes - Re-admission to hospital [3 and 6 months and annually up to 5 years]
Counting of the number of re-admission to hospital due to complications
- Exploratory endpoints: Health economic outcomes - Procedure costs [3 and 6 months and annually up to 5 years]
Evaluation of the costs related to the study procedure and the length of hospital stay
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willing and able to provide informed consent and to participate in the registry study,
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Patient's age ≥ 18 years or according to local legal age of adulthood if older,
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Documented GERD present for > 6 months,
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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)
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Suitable to undergo general anesthesia and is a suitable laparoscopic surgery candidate as determined by the investigator.
Exclusion criteria:
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Presence of para-esophageal hernia or sliding hernia > 3 centimeters,
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Known presence of delayed gastric emptying, if no other cause for acid reflux could be diagnosed,
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History of bariatric surgery wherein the stomach fundus has been extirpated,
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Female patients who are pregnant or nursing,
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Known sensitivity or allergies to silicone materials,
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Intraoperative findings determined by the investigator that may result in unfavorable conduct of the registry study procedure (as outlined in the IFU);
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mathilden Hospital | Herford | Germany | 32052 | |
| 2 | Inselspital, Universitätsspital Bern | Bern | Switzerland | 3010 | |
| 3 | Hirslanden Klinik | Bern | Switzerland | 3013 |
Sponsors and Collaborators
- Implantica CE Reflux Ltd.
Investigators
- Principal Investigator: Yves Borbély, Dr. med., Inselspital, Universitätsspital Bern
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RXI002