Clinical trial NCT00734747: Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
Official title: Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD
Gastroesophageal Reflux
Fundoplication
Endoluminal
Gastroesophageal Flap Valve
Lead sponsor: Medigus Ltd
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score
timeFrame: Six months
measure: Serious Adverse Events (SAEs)
timeFrame: 6 months
Secondary outcomes:
measure: Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test
timeFrame: 6 months
measure: Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: Vienna
country: Austria
facility: Akh Vienna City General Hospital
city: Mainz
country: Germany
facility: Med.Klinik Universitatsmedizin
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Medical Research Center
city: Milan
country: Italy
facility: Medical University of Milan - San Donato Hospital
Study officials:
affiliation: Medigus Ltd
name: Aviel Roy-Shapira, M.D.
role: STUDY_DIRECTOR
References:
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 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.
citation: 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.