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

August 13, 2008
December 30, 2015
May 2008
May 2011   (final data collection date for primary outcome measure)
  • Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.
  • Improved GERD Health Related Quality of life (GERD-HRQL - Velanovitch) scores by 50% or more [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Procedure-related adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00734747 on ClinicalTrials.gov Archive Site
  • Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduction of Proton Pump inhibitor use, as reported by subject [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • A grade I or II gastroesophageal flap valve according to the Hill classification (by endoscopy) [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • In subjects with hiatal hernia, maintenance of reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux Disease (GERD)
Device: 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 Names:
  • endoluminal treatment of GERD
  • Incisionless treatment of GERD
Experimental: Medigus SRS Endoscopic Stapling System
Endoluminal fundoplication for the treatment of GERD
Intervention: Device: Medigus SRS endoscopic stapling system

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
July 2015
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Germany,   India,   Italy
 
NCT00734747
DCLP09002
No
Not Provided
Not Provided
Aviel Roy-Shapira, M.D., MediGus Ltd
Aviel Roy-Shapira, M.D.
Not Provided
Study Director: Aviel Roy-Shapira, M.D. Medigus Ltd
Medigus Ltd
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP