Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
| Status: | Completed |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2008 |
| End Date: | July 2015 |
Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)
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.
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.
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
We found this trial at
3
sites
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