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| Sponsored by: |
NDO Surgical, Inc. |
| Information provided by: | NDO Surgical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00587392 |
Purpose
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).
| Condition | Intervention |
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Gastroesophageal Reflux Disease (GERD) |
Device: NDO Full-thickness Plicator |
| MedlinePlus related topics: | Endoscopy GERD |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results |
| Enrollment: | 33 |
| Study Start Date: | December 2004 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|
A
Active NDO Endoscopic Full-thickness Plicator Procedure
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Device: NDO Full-thickness Plicator
The NDO Full-thickness Plicator intervention was performed as part of the original open-label Plicator study as previously reported. This intervention did not take place as part of this long-term follow-up data collection study.
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients previously treated with the NDO Full-thickness Plicator in the original open-label study and who met the long-term Follow-up (LTFU) protocol inclusion and exclusion crieria were eligible for study participation.
Inclusion Criteria (required prior to original treatment):
Exclusion Criteria (required prior to original treatment):
Contacts and Locations| United States, California | |||||
| Cedars Sinai Medical Center | |||||
| Los Angeles, California, United States, 90048 | |||||
| United States, Massachusetts | |||||
| Beth Israel Deaconess Medical Center | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| United States, Minnesota | |||||
| Mayo Clinic | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| United States, New Hampshire | |||||
| Dartmouth Hitchcock Medical Center | |||||
| Lebanon, New Hampshire, United States, 03756 | |||||
| United States, South Carolina | |||||
| Medical University of South Carolina | |||||
| Charleston, South Carolina, United States, 29425 | |||||
| United States, Washington | |||||
| Virginia Mason Medical Center | |||||
| Seattle, Washington, United States, 98101 | |||||
| Canada, Ontario | |||||
| St. Michael's Hospital | |||||
| Toronto, Ontario, Canada, M4X1W4 | |||||
| NDO Surgical, Inc. |
| Principal Investigator: | Douglas Pleskow, MD | Beth Israel Deaconess Medical Center, Boston, MA |
| Principal Investigator: | Simon Lo, MD | Cedars Sinai Medical Center, Lost Angeles, CA |
| Principal Investigator: | Richard Rothstein, MD | Dartmouth Hitchcock Medical Center, Lebanon, NH |
| Principal Investigator: | Christopher Gostout, MD | Mayo Clinic, Rochester, MN |
| Principal Investigator: | Robert Hawes, MD | Medical University of South Carolina, Charleston, SC |
| Principal Investigator: | Norman Marcon, MD | St. Michael's Hospital, Toronto, Ontario, Canada |
| Principal Investigator: | Richard Kozarek, MD | Virginia Mason Medical Center, Seattle, WA |
More Information
Link to clinical study literature
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| Responsible Party: | NDO Surgical ( Bruce Gaumond, Associate Director, Clinical Affairs ) |
| Study ID Numbers: | 135-01928 |
| First Received: | December 21, 2007 |
| Last Updated: | December 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00587392 |
| Health Authority: | United States: Food and Drug Administration |
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