- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00734747
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Vienna, Austria, A-1090
- Akh Vienna City General Hospital
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Mainz, Germany
- Med.Klinik Universitatsmedizin
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Pune, India
- Deenanath Mangeshkar Hospital and Medical Research Center
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Milan, Italy
- Medical University of Milan - San Donato Hospital
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California
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San Diego, California, United States, 92103-8401
- UC San Diego
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Medigus SRS Endoscopic Stapling System
Endoluminal fundoplication for the treatment of GERD
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score
Time Frame: Six months
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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)
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Six months
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Serious Adverse Events (SAEs)
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test
Time Frame: 6 months
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Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure
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6 months
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Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject
Time Frame: 6 months
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Aviel Roy-Shapira, M.D., Medigus Ltd
Publications and helpful links
General Publications
- Zacherl J, Roy-Shapira A, Bonavina L, Bapaye A, Kiesslich R, Schoppmann SF, Kessler WR, Selzer DJ, Broderick RC, Lehman GA, Horgan S. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE) for gastroesophageal reflux disease: 6-month results from a multi-center prospective trial. Surg Endosc. 2015 Jan;29(1):220-9. doi: 10.1007/s00464-014-3731-3. Epub 2014 Aug 19.
- Kim HJ, Kwon CI, Kessler WR, Selzer DJ, McNulty G, Bapaye A, Bonavina L, Lehman GA. Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE endoscopic stapling device. Surg Endosc. 2016 Aug;30(8):3402-8. doi: 10.1007/s00464-015-4622-y. Epub 2015 Nov 4.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCLP09002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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