Phase 3 N=72 Treatment

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

Gastroesophageal Reflux Disease (GERD)

Bottom Line

View on ClinicalTrials.gov: NCT00734747 ↗

Enrolled (actual)

Serious AEs

13.9%

Results posted

Aug 2015

Primary outcome: Primary: Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score — 73 percentage of total participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Medigus SRS endoscopic stapling system (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aviel Roy-Shapira, M.D.
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score	73	—
PRIMARY Serious Adverse Events (SAEs)	8; 2	—
SECONDARY Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test	7.3	<.001 sig
SECONDARY Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject	65; 85	—

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00734747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.