Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
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.
|Gastroesophageal Reflux Disease (GERD)||Device: Medigus SRS endoscopic stapling system||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)|
- Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score [ Time Frame: Six months ]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)
- Serious Adverse Events (SAEs) [ Time Frame: 6 months ]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.
- Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test [ Time Frame: 6 months ]Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure
- Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject [ Time Frame: 6 months ]
|Study Start Date:||May 2008|
|Study Completion Date:||July 2015|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Medigus SRS Endoscopic Stapling System
Endoluminal fundoplication for the treatment of GERD
Device: Medigus SRS endoscopic stapling system
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734747
|United States, California|
|UC San Diego|
|San Diego, California, United States, 92103-8401|
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Akh Vienna City General Hospital|
|Vienna, Austria, A-1090|
|Deenanath Mangeshkar Hospital and Medical Research Center|
|Medical University of Milan - San Donato Hospital|
|Study Director:||Aviel Roy-Shapira, M.D.||Medigus Ltd|