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
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Device: MediGus SRS endoscopic stapling system
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by MediGus Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: May 2008
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734747

Locations
United States, California
UC San Diego
San Diego, California, United States, 92103-8401
United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Austria
Akh Vienna City General Hospital
Vienna, Austria, A-1090
Italy
Medical University of Milan - San Donato Hospital
Milan, Italy
Sponsors and Collaborators
Aviel Roy-Shapira, M.D.
Investigators
Study Director: Aviel Roy-Shapira, M.D. MediGus Ltd
  More Information

No publications provided

Responsible Party: Aviel Roy-Shapira, M.D., Study director, MediGus Ltd
ClinicalTrials.gov Identifier: NCT00734747     History of Changes
Other Study ID Numbers: DCLP09002
Study First Received: August 13, 2008
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MediGus Ltd:
GERD
Gastroesophageal Reflux
Fundoplication
Endoluminal
Gastroesophageal Flap Valve

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 27, 2014