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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aviel Roy-Shapira, M.D., MediGus Ltd
ClinicalTrials.gov Identifier:
NCT00734747
First received: August 13, 2008
Last updated: November 7, 2013
Last verified: November 2013

August 13, 2008
November 7, 2013
May 2008
May 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
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 ]
  • 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 ]
Same as current
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
May 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 PPIs for at least 6 months, with significant relief of symptoms (i.e., difference in 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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Italy
 
NCT00734747
DCLP09002
No
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
November 2013

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