Endoscopic Implantation of Enteryx for the Treatment of GERD
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 29, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
July 21, 2017
CompletedJuly 21, 2017
June 1, 2017
4.3 years
June 29, 2006
March 14, 2017
June 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinically Significant Reduction of PPI Usage at 12, 24, and 36 Month Follow-ups Compared to Baseline in Both Singly Treated and Retreated Patients.
Clinically significant reduction of PPI usage is defined as either elimination of medication use or reduction in dosage of ≥50% as compared to baseline. The criterion for success is defined as more than half of patients demonstrating this degree of medication reduction.
3 years either baseline to 12m, baseline to 24m, baseline to 36m
Study Arms (1)
Single Arm
EXPERIMENTALThose receiving Enteryx treatment
Interventions
Eligibility Criteria
You may qualify if:
- GERD responsive to and requiring daily PPI therapy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Endoscopy Clinical Affairs
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Yang Chen, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Clinical Professor of Medicine
Study Record Dates
First Submitted
June 29, 2006
First Posted
June 30, 2006
Study Start
October 1, 2003
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
July 21, 2017
Results First Posted
July 21, 2017
Record last verified: 2017-06