Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)

Study Overview
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Brief Summary
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The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD. The system allows the operator to staple the stomach to the esophagus,in order to restore the gastroesophageal flap valve. The effect of the stapling is similar to a common operation for GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is not needed. The hypothesis of the study is that the treatment will be effective in improving GERD related quality of life by 50% or more in the majority of the subjects, and that the procedure will be as safe as surgery.

Official Title
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Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Device: Medigus SRS endoscopic stapling system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of GERD related symptoms for at least 2 years. Recent objective evidence of GERD, demonstrated by a 24h pH acid exposure test. History of daily intake of proton pump inhibitors (PPIs) for at least 6 months, with significant relief of symptoms (i.e., difference in GERD Health Related Quality of Life (GERD HRQL) scores on and off PPI > =6). GERD-HRQL ≥20 off of PPI's Exclusion Criteria: Hiatal hernia > 3 cm or a paraesophageal hernia Barrett's esophagus or grade IV esophagitis Esophageal stricture, ring or web causing symptoms of dysphagia Grade I Flap valve according Hill's classification History of co-morbidity

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 |
| --- | --- |
| Experimental: Medigus SRS Endoscopic Stapling System<br>Endoluminal fundoplication for the treatment of GERD | Device: Medigus SRS endoscopic stapling system<br>* The system is designed to staple the stomach to the esophagus in 2 or 3 locations using a quintuplet of standard B shaped, 4.8 mm titanium staples in each location.<br>* Other names: Incisionless treatment of GERD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score | Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) questionnaire, also known as Velanovich score. The questionnaire consists of 10 questions with responses of 0-5. The responses of the 10 questions are totaled (range of 0-50) where a higher total indicates more severe disease than a lower total. This questionnaire was administered while the subjects were not taking proton pump inhibitor (PPI) medication (i.e. off-PPI). Criterion for success was an improvement >= 50% compared to baseline, at six months post procedure in at least 53% of the subjects (53% is the lower boundary of the 95% confidence interval) | Six months | 
| Serious Adverse Events (SAEs) | The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. The primary safety endpoint consisted of all treatment-related adverse events, during and after the SRS procedure. Treatment-related events were conventionally defined as those which occurred in the first 30 days post-procedure. The SAEs presented here include all SAEs from the study, including one that occurred 35 days post-procedure (suicidal behavior). There was an interim review of early Serious Adverse Events (SAEs) after the first 24 patients. Protocol and device changes were then implemented, prior to the final 48 patients. Therefore, the SAEs are presented in two categories consisting of the first 24 patients and the final 48 patients. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test | Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure | 6 months | 
| Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Gastroesophageal Reflux, Fundoplication, Endoluminal, Gastroesophageal Flap Valve