Registry Study of the NDO Surgical Plicator for the Treatment of GERD
Public ClinicalTrials.gov record NCT00597792. 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 study is to collect post-marketing data on patient outcomes and satisfaction following treatment with the Plicator™. The outcomes will be tracked through analysis of patient Quality of Life (QoL) questionnaires and medication use. The QoL and medication use questionaires will be administered and documented twice before the procedure and then again at outlined intervals following the procedure. Additionally, financial measures will be evaluated (i.e. pre-procedural and procedural time and costs, staffing/personnel needs during procedure, anesthesia and related costs, recovery time and associated cost, etc.) and post-procedure GERD-related medical history questionnaires will be completed. This post-market evaluation is a multi-center study design using the NDO Surgical, Inc. Plicator as the treatment device. Treatment efficacy will be evaluated by comparing QoL and medication use before and after treatment with the device. Patient follow-ups will be completed at 1 week and at 6, 12, 24, 36, 48 and 60 months post treatment.
Study identification
- NCT ID
- NCT00597792
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 131 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
- Aug 2004 (Type not available)
- Primary completion
- Nov 2007 (Actual)
- Completion
- Nov 2007 (Actual)
- Last update posted
- May 30, 2008
2004 – 2007
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Center of Central Georgia | Macon | Georgia | 31201 | — |
| Evanston Northwestern Healthcare | Evanston | Illinois | 60201 | — |
| Northside Gastroenterology, Inc. | Indianapolis | Indiana | 46260 | — |
| Lenox Hill Hospital | New York | New York | 10021 | — |
| Stony brook University Medical Center | Stony Brook | New York | 11794 | — |
| Nashville Medical Research and the Maria Nathanson Center of Excellence | Nashville | Tennessee | 37205 | — |
| Digestive Associates of Houston | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00597792, 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 May 30, 2008 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00597792 live on ClinicalTrials.gov.