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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RefluxStop patients |
| ||
| Nissen fundoplication patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RefluxStop implantation | Device | Standard surgical technique for implantation RefluxStop, as described in the Itructions for Use |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory endpoints: Patient Reported Outcomes - Quality of life questionnaire | 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. |
Inclusion Criteria:
Exclusion criteria:
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RefluxStop device and Nissen fundoplication are indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) defined by abnormal pH testing.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Souheila Moutiq | Contact | +41 78 249 77 28 | souheila.moutiq@implantica.com |
| Name | Affiliation | Role |
|---|---|---|
| Yves Borbély, Dr. med. | Inselspital, Universitätsspital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Friedrichshafen GmbH | Active, not recruiting | Friedrichshafen | 88048 | Germany | ||
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D018662 | Fundoplication |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Nissen fundoplication | Procedure | Standard of care Nissen fundoplication surgery |
|
| 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 |
| 3 and 6 months and annually up to 5 years |
| Exploratory endpoints: Patient Reported Outcomes - Work related questionnaire | 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 | 3 and 6 months and annually up to 5 years |
| Exploratory endpoints: Health economic outcomes - Visit to General Practitioner | Evaluation of number of visit to the General Practitioner | 3 and 6 months and annually up to 5 years |
| Exploratory endpoints: Health economic outcomes - PPI treatment use | Counting of the number of patients using PPI (Proton Pump Inhibitors) | 3 and 6 months and annually up to 5 years |
| Exploratory endpoints: Health economic outcomes - Re-admission to hospital | Counting of the number of re-admission to hospital due to complications | 3 and 6 months and annually up to 5 years |
| Exploratory endpoints: Health economic outcomes - Procedure costs | Evaluation of the costs related to the study procedure and the length of hospital stay | 3 and 6 months and annually up to 5 years |
| Ospedale IRCCS Saverio De Bellis |
| Recruiting |
| Bari |
| 70013 |
| Italy |
|
| Ospedale Buon Consiglio Fatebenefratelli | Recruiting | Naples | 80123 | Italy |
|
| Akershus Universitetssykehus HF | Recruiting | Lørenskog | 1478 | Norway |
|
| Inselspital, Universitätsspital Bern | Recruiting | Bern | 3010 | Switzerland |
|
| Hirslanden Klinik | Recruiting | Bern | 3013 | Switzerland |
|
| D004066 | Digestive System Diseases |