Status:
COMPLETED
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
Aviel Roy-Shapira, M.D.
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00734747
Start Date
May 1 2008
End Date
July 1 2015
Last Update
February 2 2016
Active Locations (6)
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1
UC San Diego
San Diego, California, United States, 92103-8401
2
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
3
Akh Vienna City General Hospital
Vienna, Austria, A-1090
4
Med.Klinik Universitatsmedizin
Mainz, Germany