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

NCT00734747 | Completed Phase 3 Results

• 1 other identifier: DCLP09002
• Study Type: interventional
• Target: 72
• Locations: 5 countries
• Sites: 6

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.

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

GERD; Gastroesophageal Reflux; Fundoplication; Endoluminal; Gastroesophageal Flap Valve

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test

  6 months

• Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject

  6 months

Study Arms (1)

Medigus SRS Endoscopic Stapling System

EXPERIMENTAL

Endoluminal fundoplication for the treatment of GERD

Device: Medigus SRS endoscopic stapling system

Interventions

Medigus SRS endoscopic stapling system DEVICE

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.

Also known as: endoluminal treatment of GERD, Incisionless treatment of GERD

Medigus SRS Endoscopic Stapling System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aviel Roy-Shapira, M.D.: lead

Study Sites (6)

UC San Diego

San Diego, California, 92103-8401, United States

Location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Akh Vienna City General Hospital

Vienna, A-1090, Austria

Location

Med.Klinik Universitatsmedizin

Mainz, Germany

Location

Deenanath Mangeshkar Hospital and Medical Research Center

Pune, India

Location

Medical University of Milan - San Donato Hospital

Milan, Italy

Location

Related Publications (2)

• 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 disease: 6-month results from a multi-center prospective trial. Surg Endosc. 2015 Jan;29(1):220-9. doi: 10.1007/s00464-014-3731-3. Epub 2014 Aug 19.

  PMID: 25135443 RESULT

• 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. 2016 Aug;30(8):3402-8. doi: 10.1007/s00464-015-4622-y. Epub 2015 Nov 4.

  PMID: 26537905 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Aviel Roy-Shapira, MD
• Organization: Medigus Ltd

avrish@gmail.com

+972 8646 6880

Study Officials

• Aviel Roy-Shapira, M.D.

  Medigus Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study director

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2015
• Last Updated: February 2, 2016
• Results First Posted: August 14, 2015

Record last verified: 2015-12

Locations

IN (1); AU (1); IT (1); DE (1); US (2)