Trial Outcomes & Findings for Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD) (NCT NCT00734747)

Last Updated: 2016-02-02

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

72 participants

Primary outcome timeframe

Six months

Results posted on

2016-02-02

Participant Flow

Participant milestones

Participant milestones
Measure	Medigus SRS Endoscopic Stapling System Endoluminal fundoplication for the treatment of GERD 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.
SRS Procedure STARTED	72
SRS Procedure COMPLETED	69
SRS Procedure NOT COMPLETED	3
6 Month Follow-up STARTED	69
6 Month Follow-up COMPLETED	66
6 Month Follow-up NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Medigus SRS Endoscopic Stapling System Endoluminal fundoplication for the treatment of GERD 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.
SRS Procedure No staples placed	3
6 Month Follow-up Did not meet inclusion criteria	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medigus SRS Endoscopic Stapling System n=72 Participants Endoluminal fundoplication for the treatment of GERD 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.
Age, Continuous	47.5 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment Austria	9 participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants
Region of Enrollment Italy	5 participants n=5 Participants
Region of Enrollment Germany	7 participants n=5 Participants
Region of Enrollment India	13 participants n=5 Participants
BMI	26.5 kg/m^2 STANDARD_DEVIATION 4.3 • n=5 Participants
GERD HRQL on PPI	15 units on a scale STANDARD_DEVIATION 7.5 • n=5 Participants
GERD HRQL off PPI	29 units on a scale STANDARD_DEVIATION 6.2 • n=5 Participants
% total time pH < 4	10.9 % total time STANDARD_DEVIATION 10.7 • n=5 Participants
Hill Grade Hill Grade <= 2	22 participants n=5 Participants
Hill Grade Hill Grade >=2	43 participants n=5 Participants
Hill Grade No baseline measurement	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months

Outcome measures

Outcome measures
Measure	Medigus SRS Endoscopic Stapling System n=66 Participants Endoluminal fundoplication for the treatment of GERD 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.
Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score	73 percentage of total participants Interval 60.0 to 83.0

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Medigus SRS Endoscopic Stapling System n=72 Participants Endoluminal fundoplication for the treatment of GERD 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.
Serious Adverse Events (SAEs) Serious Adverse Event - First 24 patients	8 participants
Serious Adverse Events (SAEs) Serious Adverse Events - final 48 participants	2 participants

SECONDARY outcome

Timeframe: 6 months

Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure

Outcome measures

Outcome measures
Measure	Medigus SRS Endoscopic Stapling System n=64 Participants Endoluminal fundoplication for the treatment of GERD 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.
Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test	7.3 percentage of time pH <4.0 Standard Deviation 5.1

SECONDARY outcome

Timeframe: 6 months

Population: Note: 1 of the 66 participants was not taking proton pump inhibitors (PPIs) at baseline, therefore they were excluded from the analysis of PPI use reduction.

Outcome measures

Outcome measures
Measure	Medigus SRS Endoscopic Stapling System n=65 Participants Endoluminal fundoplication for the treatment of GERD 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.
Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject % patients who eliminated PPI use	65 percentage of subjects Interval 52.0 to 76.0
Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject % patients who reduced PPI use by >50%	85 percentage of subjects Interval 72.0 to 92.0

Adverse Events

Medigus SRS Endoscopic Stapling System

Serious events: 10 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Medigus SRS Endoscopic Stapling System n=72 participants at risk Endoluminal fundoplication for the treatment of GERD 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.
Gastrointestinal disorders Upper GI bleed	1.4% 1/72 • Number of events 1 • 6 months
Infections and infestations Pain and fever	5.6% 4/72 • Number of events 4 • 6 months
Infections and infestations Viral infection	1.4% 1/72 • Number of events 1 • 6 months
Psychiatric disorders Suicidal behavior	1.4% 1/72 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Pleural effusion, esophageal leak	1.4% 1/72 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	1.4% 1/72 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Pneumothorax/pneumoperitoneum	2.8% 2/72 • Number of events 2 • 6 months

Other adverse events

Other adverse events
Measure	Medigus SRS Endoscopic Stapling System n=72 participants at risk Endoluminal fundoplication for the treatment of GERD 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.
Gastrointestinal disorders Increase belching	5.6% 4/72 • Number of events 4 • 6 months
Musculoskeletal and connective tissue disorders Shoulder pain	6.9% 5/72 • Number of events 5 • 6 months
Respiratory, thoracic and mediastinal disorders Atelectasis	8.3% 6/72 • Number of events 6 • 6 months
Respiratory, thoracic and mediastinal disorders Chest pain	22.2% 16/72 • Number of events 16 • 6 months
Respiratory, thoracic and mediastinal disorders Sore throat	20.8% 15/72 • Number of events 15 • 6 months

Additional Information

Aviel Roy-Shapira, MD

Medigus Ltd

Phone: +972 8646 6880

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60