Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
GERD, Gastroesophageal Reflux, Fundoplication, Endoluminal, Gastroesophageal Flap Valve
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.
Interventions
DEVICEMedigus 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.
Sponsors
Aviel Roy-Shapira, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score | Six months | 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) |
| Serious Adverse Events (SAEs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject | 6 months | — |
| Reduction of Acid Exposure (%Time pH<4) on Off PPI Ambulatory 24h Acid Exposure Test | 6 months | Esophageal pH (off PPI therapy) was measured in 66 patients pre-procedure and 64 patients at 6 months post-procedure |
Countries
Austria, Germany, India, Italy, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 6 Month Follow-up | Did not meet inclusion criteria | 3 |
| SRS Procedure | No staples placed | 3 |
Baseline characteristics
| Characteristic | Medigus SRS Endoscopic Stapling System |
|---|---|
| Age, Continuous | 47.5 years |
| BMI | 26.5 kg/m^2 STANDARD_DEVIATION 4.3 |
| GERD HRQL off PPI | 29 units on a scale STANDARD_DEVIATION 6.2 |
| GERD HRQL on PPI | 15 units on a scale STANDARD_DEVIATION 7.5 |
| Hill Grade Hill Grade <= 2 | 22 participants |
| Hill Grade Hill Grade >=2 | 43 participants |
| Hill Grade No baseline measurement | 7 participants |
| Region of Enrollment Austria | 9 participants |
| Region of Enrollment Germany | 7 participants |
| Region of Enrollment India | 13 participants |
| Region of Enrollment Italy | 5 participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 42 Participants |
| % total time pH < 4 | 10.9 % total time STANDARD_DEVIATION 10.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 43 / 72 |
| serious Total, serious adverse events | 10 / 72 |
Outcome results
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)
Time frame: Six months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medigus SRS Endoscopic Stapling System | Percentage of Participants With >= 50% Improvement in GERD Health Related Quality of Life (GERD-HRQL - Velanovich) Score | 73 percentage of total participants |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medigus SRS Endoscopic Stapling System | Serious Adverse Events (SAEs) | Serious Adverse Event - First 24 patients | 8 participants |
| Medigus SRS Endoscopic Stapling System | Serious Adverse Events (SAEs) | Serious Adverse Events - final 48 participants | 2 participants |
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
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medigus SRS Endoscopic Stapling System | 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 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medigus SRS Endoscopic Stapling System | Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject | % patients who eliminated PPI use | 65 percentage of subjects |
| Medigus SRS Endoscopic Stapling System | Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject | % patients who reduced PPI use by >50% | 85 percentage of subjects |