GERD heartburn
Conditions
Interventions
At screening and at 12 months post procedure:
Esophageal manometry + pH -impedance test
pH test by Bravo capsule
Endoscopy
Barium swallow
chest x-ray
At 24 and 60 months Endoscopy and chest/abdomina
Sponsors
Torax medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age * 19 years - * 75 years Suitable surgical candidate Patient requires daily PPI or other anti-reflux therapy Total distal Ambulatory Esophageal pH must be * 4.5% of the time * pH4 GERD symptoms in absence of anti-reflux therapy Subject has signed an ICF
Exclusion criteria
Exclusion criteria: The procedure is an emergency procedure Patient is currently being treated with another investigational drug or investigational device Prior gastric esophageal surgery Any previous endoscopic anti-reflux intervention for GERD and /or previous endoscopic intervention for treatment of Barret's esophagus Suspected or confirmed esophageal or gastric cancer Hiatal hernia > 3 cm Esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or 35 Allergies to titanium, stainless steel, nickel or ferrous materials Diagnosed psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary safety endpoint: The primary safety endpoint is the rate of occurrence for serious de-vice and procedure related adverse events. The primary safety end-point will be assessed by reporting all adverse events and by esti-mating the rate of serious device and procedure related adverse events through 12 months post implantation. Safety will also be evaluated by endoscopy to assess the mucosa and abdominal/chest X-ray evaluations to verify device location at 12 months post im-plantation. Primary effectiveness endpoints: Reduction in total distal esophageal acid exposure time defined by esophageal pH testing. Testing will be performed with subjects off PPIs. The subject*s baseline pH acid exposure time will serve as the control and be compared to the subject*s pH acid exposure time 12 months post implantation. Success criteria * At least 60% of subjects will have nor-malized or improved by at least 50% in total distal acid exposure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary effectiveness endpoints: Subjects GERD-HRQL (Health Related Quality of Life) scores will be assessed off all GERD medications. The subject*s baseline GERD-HRQL score will serve as the control and be compared to the sub-ject*s GERD-HRQL 12 months post implantation. Success criteria - At least 60% of subjects will have a 50% reduction in total GERD-HRQL scores Subject*s average daily dose of PPI will be evaluated. The subject*s baseline average daily dosage will serve as the control and be com-pared to the subject*s average daily dosage 12 months post-procedure. Success criteria - At least 60% of subjects will reduce their average daily PPI dosage *50% Number of TLESR's | — |
Countries
Netherlands
Outcome results
None listed