Status:
COMPLETED
Endoscopic Implantation of Enteryx for the Treatment of GERD
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
Phase:
NA
Brief 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.
Detailed Description
The Enteryx procedure kit is indicated for endoscopic injection into the region of the lower esophageal sphincter (LES) for the treatment of symptoms due to gastroesophageal reflux disease (GERD) symp...
Eligibility Criteria
Inclusion
- GERD responsive to and requiring daily PPI therapy
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00346905
Start Date
October 1 2003
End Date
February 1 2008
Last Update
July 21 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215