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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2010 by MediGus Ltd.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

MediGus Ltd

ClinicalTrials.gov Identifier:

NCT00734747

First received: August 13, 2008

Last updated: December 5, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 13, 2008

Last Updated Date

December 5, 2010

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00734747 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gastroesophageal Reflux Disease (GERD)

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2011

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria

Administrative Information

NCT Number ^ICMJE

NCT00734747

Other Study ID Numbers ^ICMJE

DCLP09002

Has Data Monitoring Committee

Responsible Party

Aviel Roy-Shapira, M.D. Chief Medical Officer, MediGus Ltd.

Study Sponsor ^ICMJE

MediGus Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Aviel Roy-Shapira, M.D.

MediGus Ltd

Information Provided By

MediGus Ltd

Verification Date

December 2010

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

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