GERD
Conditions
Interventions
The subjects will be randomized to receive the Endoscopy Gatekeeper prostheses or to the endoscopy sham control group with 96 subjects in the treatment arm and 48 subjects in the sham control arm. At
Sponsors
Medtronic Gastroenterology/Urology
4000 Lexington Avenue North
Shreview, MN 55126-3755
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must be at least 18 years of age; 2. Subjects with documented typical symptoms of GERD; 3. Female subjects of child bearing potential must have a negative pregnancy test within 1 week before treatment and must agree to use an effective means of birth control during participation in the study; 4. Subjects who show symptomatic improvemnet on PPI and want to discontinue their GERD medication; 5. Subjects who have demonstrated a baseline 24 hour ph> 4% time with pH 20 off PPI; 7. Subjects who have been informed of the nature of the study and have agreed to its provisions and provided ICF, approved by the Institutional Review Board or Medical Ethics Committee of the respective clinical site.
Exclusion criteria
Exclusion criteria: 1. Cassified in anesthesia risk group, ASA Class III-IV; 2. Extensive barret's esophagus (> 2cm); 3. Esophagitis (Grades III-IV); 4. Complaints of dysphagia; 5. Esophageal strictures; 6. Esophageal or gastric varices; 7. Previous history of gastroesophgeal surgery, anti-reflux procedures, or gastroesophageal or gastric cancer; 8. Large hiatal hernia (> 3cm); 9. Ineffective esophageal motility, defined as amplitudes of 50% of the time; 10. Diagnosed with morbid obesity (BMI >35); 11. Immunocompromised subjects (subjects diagnosed with HIV, on chronic steroid use or other immunosuppressants, such as Immuran); 12. History of bleeding diathesis or coagulopathy or who will refuse blood transfusions; 13. Inability to discontinue anticoagulation therapy; 14. Suffered a stroke or transient ischemic neurological attack (TIA) within the past 6 months; 15. Experienced a hematologically significant gastrointestinal bleed within the past 6 months; 16. Has other medical illness that may cause the subject to be non-compliant with or unable to meet the requirements of the protocol or is associatedwith limited life expectancy; 17. Simultaneously participating in another device or drug study, or who has participated in any clincal trila involving an experimental device within 6 months or experimental drug within 30 days of study entry; 18. Unable or unwilling to cooperate with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious device- and procedure related adverse device effects (whether anicipated or unanticipated) at 6 months post procedure and the subject's associated symptoms of heartburn at 6 months post procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improved esophageal pH defined as the total percent of time that pH is less tha 4 at 6 months post Gatekeeper procedure as compared to baseline. | — |
Contacts
Public ContactA. Lei
Academic Medical Center (AMC), Motility Center, C2 room 311, P.O. Box 22660
Outcome results
None listed