INX* Reflux Management System Clinical Study
- Conditions
- GERDheartburn10017943
- Registration Number
- NL-OMON37296
- Lead Sponsor
- Torax medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
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
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 < 70% (propulsive) peristaltic sequences
Esophagitis grade C-D
Symptoms of dysphagia more than once a week within the last 3 months
Patient diagnosed with scleroderma or achalasia, Nutcracker esophagus
Gross esophageal anatomic abnormalities or esophgeal stricture
Patient is pregnant or nursing or plans to become pregnant
Patient has Barret esophagus
BMI>35
Allergies to titanium, stainless steel, nickel or ferrous materials
Diagnosed psychiatric disorders
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method