Back to resultsSafety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
Primary Purpose
Gastroesophageal Reflux Disease (GERD)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Medigus SRS endoscopic stapling system
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring GERD, Gastroesophageal Reflux, Fundoplication, Endoluminal, Gastroesophageal Flap Valve
Eligibility Criteria
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
Sites / Locations
- UC San Diego
- Indiana University Hospital
- Akh Vienna City General Hospital
- Med.Klinik Universitatsmedizin
- Deenanath Mangeshkar Hospital and Medical Research Center
- Medical University of Milan - San Donato Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medigus SRS Endoscopic Stapling System
Arm Description
Endoluminal fundoplication for the treatment of GERD
Outcomes
Primary Outcome Measures
Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score
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)
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
Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test
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
Full Information
NCT ID
NCT00734747
First Posted
August 13, 2008
Last Updated
December 30, 2015
Sponsor
Aviel Roy-Shapira, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT00734747
Brief Title
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
Official Title
Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aviel Roy-Shapira, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD)
Keywords
GERD, Gastroesophageal Reflux, Fundoplication, Endoluminal, Gastroesophageal Flap Valve
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medigus SRS Endoscopic Stapling System
Arm Type
Experimental
Arm Description
Endoluminal fundoplication for the treatment of GERD
Intervention Type
Device
Intervention Name(s)
Medigus SRS endoscopic stapling system
Other Intervention Name(s)
endoluminal treatment of GERD, Incisionless treatment of GERD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score
Description
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)
Time Frame
Six months
Title
Serious Adverse Events (SAEs)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test
Description
Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure
Time Frame
6 months
Title
Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aviel Roy-Shapira, M.D.
Organizational Affiliation
Medigus Ltd
Official's Role
Study Director
Facility Information:
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8401
Country
United States
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Akh Vienna City General Hospital
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Med.Klinik Universitatsmedizin
City
Mainz
Country
Germany
Facility Name
Deenanath Mangeshkar Hospital and Medical Research Center
City
Pune
Country
India
Facility Name
Medical University of Milan - San Donato Hospital
City
Milan
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
25135443
Citation
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.
Results Reference
result
PubMed Identifier
26537905
Citation
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.
Results Reference
result
Learn more about this trial
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
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