Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
NCT ID: NCT00734747
Last Updated: 2016-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
72 participants
INTERVENTIONAL
2008-05-31
2015-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Medigus SRS Endoscopic Stapling System
Endoluminal fundoplication for the treatment of GERD
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Aviel Roy-Shapira, M.D.
INDUSTRY
Responsible Party
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Aviel Roy-Shapira, M.D.
Study director
Principal Investigators
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Aviel Roy-Shapira, M.D.
Role: STUDY_DIRECTOR
Medigus Ltd
Locations
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UC San Diego
San Diego, California, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Akh Vienna City General Hospital
Vienna, , Austria
Med.Klinik Universitatsmedizin
Mainz, , Germany
Deenanath Mangeshkar Hospital and Medical Research Center
Pune, , India
Medical University of Milan - San Donato Hospital
Milan, , Italy
Countries
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References
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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.
Other Identifiers
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DCLP09002
Identifier Type: -
Identifier Source: org_study_id
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