GERD heartburn
Conditions
Interventions
The participating subjects will get the following tests in the screening period:
Endoscopy
24hr pH assesment
LES manometry
Fluoroscopy (barium esophgram)
All enrolled patients will receive the magne
Sponsors
Torax Medical, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age _>18 years, 3 years Documented history of GERD symptoms such as heartburn and regurgitation On daily PPI treatment for at least 3 months with partially response GERD symptoms in absence of PPI theapy Ambulatory Esophageal pH5% or pH 3% time in supine Patient is a surgical candidate Patient is able to understand provide written ICF
Exclusion criteria
Exclusion criteria: The procedure is an emergency procedure Patient is currently being treated with another investigational drug mechanical support device Prior gastric or esophageal surgery Any endoscopic intervention Suspected or confirmed esophageal or gastric cancer Hiatal hernia _>3 cm Esophageal motility less than 30 mmHg peristaltic amplitude on wet swallows and/or > 30% synchronous/repetitive waves Esophagitis grade IV Symptoms of dysphagia or indications of dysphagia from esophagram Patient has scleroderma and or achalasia Gross esophageal anatomic abnormalities patient is pregnant or nursing or plans to become pregnant Barret esophagus BMI >35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Verification of the procedural methods for placing the Magnetic Esophageal Sphincter around the LES. • Evaluate the physiological function of the implant with manometry, fluoroscopy, and endoscopy. Additional assessment and further diagnostics if deemed necessary by investigator. • Evaluate the reduction of GERD by patient symptomology interview at all follow-up visits and 24hr pH profile at the six month follow-up visit. | — |
Countries
Netherlands
Outcome results
None listed