Overview
Endoscopic Implantation of Enteryx for the Treatment of GERD
Status:
Completed
Completed
Trial end date:
2008-02-01
2008-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The study objective is to assess the long term safety and effectiveness of Enteryx device in commercial use. The long-term effects beyond one year of treatment with Enteryx have not been established.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Beth Israel Deaconess Medical Center
Criteria
Inclusion Criteria:- GERD responsive to and requiring daily PPI therapy
Exclusion Criteria:
- Esophageal varices, particularly related to portal hypertension • Patients whom the
physician determines to be a poor candidate for endoscopic procedures and/or
anesthesia.
Patients must also be willing to allow their data to be shared with the Sponsor and FDA.