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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734747
• Other study ID #: DCLP09002
• Status: Completed
• Phase: Phase 3
• First received: August 13, 2008
• Last updated: December 30, 2015
• Start date: May 2008
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: MediGus Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2015
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

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.

Locations

Country	Name	City	State
Austria	Akh Vienna City General Hospital	Vienna
Germany	Med.Klinik Universitatsmedizin	Mainz
India	Deenanath Mangeshkar Hospital and Medical Research Center	Pune
Italy	Medical University of Milan - San Donato Hospital	Milan
United States	Indiana University Hospital	Indianapolis	Indiana
United States	UC San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Aviel Roy-Shapira, M.D.

Countries where clinical trial is conducted

United States,  Austria,  Germany,  India,  Italy, 

References & Publications (2)

Kim HJ, Kwon CI, Kessler WR, Selzer DJ, McNulty G, Bapaye A, Bonavina L, Lehman GA. Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device. Surg Endosc. 2015 Nov 4. [Epub ahead of p — View Citation

Zacherl J, Roy-Shapira A, Bonavina L, Bapaye A, Kiesslich R, Schoppmann SF, Kessler WR, Selzer DJ, Broderick RC, Lehman GA, Horgan S. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score	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)	Six months	No
Primary	Serious Adverse Events (SAEs)	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.	6 months	Yes
Secondary	Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test	Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure	6 months	No
Secondary	Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject		6 months	No