Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results
Completed
Conditions studied: Gastroesophageal Reflux Disease (GERD)
In brief
The purpose of this study was to gather long-term follow-up data on patients treated with the Plicator in a previous open-label multi-center study. Originally, 64 subjects were treated at seven U.S. sites. A subset of those patients were subsequently reassessed via symptom questionnaires in this long-term (60-month) follow-up analysis. The initial open-label study was completed and officially closed at the completion of 1-year follow-up. This current study was designed to collect long-term follow-up data on previously plicated subjects all of whom were recruited de novo from the original study population. Study endpoints were prospectively defined. The primary study objectives were to assess: reduction in GERD symptoms through analysis of the GERD Health Related Quality of Life (HRQL) questionnaire and the Gastrointestinal Symptom Rating Scale (GSRS); reduction in use of GERD medications, and change in overall physical and psychological health as measured by the Short Form Health Survey (SF-36).
Key facts
- Study ID
- NCT00587392
- Run by
- NDO Surgical, Inc.
- People needed
- 33
- Starts
- 2004-12-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2008-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Virginia Mason Medical Center — Seattle, Washington, United States
- St. Michael's Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.