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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD)
• Interventions: Device: Medigus SRS endoscopic stapling system

• Registration Number: NCT00734747
• Lead Sponsor: Aviel Roy-Shapira, M.D.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2011-05
• Results First Submitted: 2015-05-15
• Study Completion: 2015-07
• Results First Submitted QC: 2015-07-15
• Results First Posted: 2015-08-14
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medigus SRS Endoscopic Stapling System	Medigus SRS endoscopic stapling system	Endoluminal fundoplication for the treatment of GERD

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score	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)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

UC San Diego; 🇺🇸 San Diego, California, United States

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

Med.Klinik Universitatsmedizin; 🇩🇪 Mainz, Germany

Akh Vienna City General Hospital; 🇦🇹 Vienna, Austria

Deenanath Mangeshkar Hospital and Medical Research Center; 🇮🇳 Pune, India

Medical University of Milan - San Donato Hospital; 🇮🇹 Milan, Italy