Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease
Public ClinicalTrials.gov record NCT00587522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this prospective, multicenter study was to evaluate the safety and efficacy of endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux. Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. All patients received a single implant/plication. No repeat plication procedures were performed. Primary efficacy in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. Secondary efficacy outcomes included post-procedure reduction in anti-secretory therapy, improvement in quality of life questionnaires, reduction in distal esophageal acid exposure, and improvement in esophageal manometry. Patient follow-up assessments were completed at 1, 3, 6 and 12 months post treatment.
Study identification
- NCT ID
- NCT00587522
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 64 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2001
- Primary completion
- Apr 30, 2003
- Completion
- Apr 30, 2003
- Last update posted
- Jan 6, 2008
2001 – 2003
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00587522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 6, 2008 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00587522 live on ClinicalTrials.gov.