N/A
N=16
Endoscopic Implantation of Enteryx for the Treatment of GERD
Gastroesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00346905 ↗Enrolled (actual)
16
Serious AEs
62.5%
Results posted
Jul 2017
Primary outcome: Primary: Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients. — 56.25; 45.45; 50.00 % of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enteryx (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients. |
56.25; 45.45; 50.00 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00346905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.