Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aviel Roy-Shapira, M.D., MediGus Ltd
ClinicalTrials.gov Identifier:
NCT00734747
First received: August 13, 2008
Last updated: December 30, 2015
Last verified: December 2015
Results First Received: May 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux Disease (GERD)
Intervention: Device: Medigus SRS endoscopic stapling system

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow for 2 periods

Period 1:   SRS Procedure
    Medigus SRS Endoscopic Stapling System  
STARTED     72  
COMPLETED     69  
NOT COMPLETED     3  
No staples placed                 3  

Period 2:   6 Month Follow-up
    Medigus SRS Endoscopic Stapling System  
STARTED     69  
COMPLETED     66  
NOT COMPLETED     3  
Did not meet inclusion criteria                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects consented for enrollment

Reporting Groups
  Description
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.


Baseline Measures
    Medigus SRS Endoscopic Stapling System  
Number of Participants  
[units: participants]
  72  
Age  
[units: years]
Median (Full Range)
  47.5  
  (24 to 74)  
Gender  
[units: participants]
 
Female     30  
Male     42  
Region of Enrollment  
[units: participants]
 
Austria     9  
United States     38  
Italy     5  
Germany     7  
India     13  
BMI [1]
[units: kg/m^2]
Mean (Standard Deviation)
  26.5  (4.3)  
GERD HRQL on PPI [2]
[units: units on a scale]
Median (Standard Deviation)
  15  (7.5)  
GERD HRQL off PPI [3]
[units: units on a scale]
Median (Standard Deviation)
  29  (6.2)  
% total time pH < 4 [4]
[units: % total time]
Mean (Standard Deviation)
  10.9  (10.7)  
Hill Grade [5]
[units: participants]
 
Hill Grade <= 2     22  
Hill Grade >=2     43  
No baseline measurement     7  
[1] Body Mass Index
[2] 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 taking proton pump inhibitor (PPI) medication.
[3] 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)
[4] Ambulatory, 24 hour esophageal pH measurement; Baseline value calculated for n=66 participants evaluated at 6 months.
[5] Hill Scores indicating the status of the patients' Gastroesophageal Flap Valve (GEFV). A satisfactory flap valve has a Hill Grade of 1 or 2.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score   [ Time Frame: Six months ]

2.  Primary:   Serious Adverse Events (SAEs)   [ Time Frame: 6 months ]

3.  Secondary:   Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test   [ Time Frame: 6 months ]

4.  Secondary:   Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aviel Roy-Shapira, MD
Organization: Medigus Ltd
phone: +972 8646 6880
e-mail: avrish@gmail.com


Publications of Results:

Responsible Party: Aviel Roy-Shapira, M.D., MediGus Ltd
ClinicalTrials.gov Identifier: NCT00734747     History of Changes
Other Study ID Numbers: DCLP09002
Study First Received: August 13, 2008
Results First Received: May 15, 2015
Last Updated: December 30, 2015
Health Authority: United States: Food and Drug Administration