Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

Study Overview
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Brief Summary
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A prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with GERD. The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement

Official Title
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A Prospective Multi Center Case Controlled Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: endoscopic full thickness plication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent; ≥ 18 years of age; GERD documented by 24h ambulatory Multichannel Impedance-pH-Monitoring off antisecretory therapy and/or Gastroscopy by one or more of the following criteria: Total Number of Reflux Events ≥ 73/24h; DeMeester Score ≥ 14.7; Positive Symptom Index - SI ≥ 50% for Symptoms troublesome for the Patient with a Frequency of at least 3/24hrs; Macroendoscopically distinct mucosal breaks. Exclusion Criteria: Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction; ≤ 18 years of age; Pregnancy and lactation; Previous extensive abdominal surgery; Previous esophageal or gastric surgery; Hiatal hernia >2cm; paraesophageal hernia; American Society of Anaesthesiologists physical status classification >II

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: full thickness gastroplication<br> | Procedure: endoscopic full thickness plication<br> <br> * Other names: GERDx™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life using the Gastrointestinal Quality of Life Index |  | change from baseline in Quality of Life at 3 months, one year and three years after the intervation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower esophageal sphincter pressure using oesophageal manometry |  | change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion | 
| DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment |  | change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD