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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medigus SRS Endoscopic Stapling System | Experimental | Endoluminal fundoplication for the treatment of GERD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aviel Roy-Shapira, M.D. | Medigus Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | San Diego | California | 92103-8401 | United States | ||
| Indiana University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25135443 | Result | 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. | |
| 26537905 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| SRS Procedure |
|
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|
| 6 months |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Akh Vienna City General Hospital | Vienna | A-1090 | Austria |
| Med.Klinik Universitatsmedizin | Mainz | Germany |
| Deenanath Mangeshkar Hospital and Medical Research Center | Pune | India |
| Medical University of Milan - San Donato Hospital | Milan | Italy |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| 6 Month Follow-up |
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All subjects consented for enrollment
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| BMI | Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||||||
| GERD HRQL on PPI | 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 taking proton pump inhibitor (PPI) medication. | Median | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| GERD HRQL off PPI | 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) | Median | Standard Deviation | units on a scale |
| |||||||||||||||||||||
| % total time pH < 4 | Ambulatory, 24 hour esophageal pH measurement; Baseline value calculated for n=66 participants evaluated at 6 months. | Mean | Standard Deviation | % total time |
| |||||||||||||||||||||
| Hill Grade | Hill Scores indicating the status of the patients' Gastroesophageal Flap Valve (GEFV). A satisfactory flap valve has a Hill Grade of 1 or 2. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Number | 95% Confidence Interval | percentage of total participants | Six months |
|
|
| ||||||||||||||||||||||||||
| 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. | Posted | Number | participants | 6 months |
|
| ||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | percentage of time pH <4.0 | 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Reduction of Proton Pump Inhibitor (PPI) Use, as Reported by Subject | 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. | Posted | Number | 95% Confidence Interval | percentage of subjects | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 10 | 72 | 43 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper GI bleed | Gastrointestinal disorders |
| |||
| Pain and fever | Infections and infestations |
| |||
| Viral infection | Infections and infestations |
| |||
| Suicidal behavior | Psychiatric disorders |
| |||
| Pleural effusion, esophageal leak | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumothorax/pneumoperitoneum | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase belching | Gastrointestinal disorders |
| |||
| Shoulder pain | Musculoskeletal and connective tissue disorders |
| |||
| Atelectasis | Respiratory, thoracic and mediastinal disorders |
| |||
| Chest pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Sore throat | Respiratory, thoracic and mediastinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aviel Roy-Shapira, MD | Medigus Ltd | +972 8646 6880 | avrish@gmail.com |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Italy |
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| Germany |
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| India |
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| No baseline measurement |
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