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Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results

NCT00587392 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2008-01-07

No results posted yet for this study

Summary

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).

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

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.

Sponsors & Collaborators

  • NDO Surgical, Inc.

    lead INDUSTRY

Principal Investigators

  • Douglas Pleskow, MD · Beth Israel Deaconess Medical Center, Boston MA

  • Simon Lo, MD · Cedars Sinai Medical Center, Lost Angeles, CA

  • Richard Rothstein, MD · Dartmouth Hitchcock Medical Center, Lebanon, NH

  • Christopher Gostout, MD · Mayo Clinic, Rochester, MN

  • Robert Hawes, MD · Medical University of South Carolina

  • Norman Marcon, MD · St. Michael's Hospital, Toronto, Ontario, Canada

  • Richard Kozarek, MD · Virginia Mason Medical Center, Seattle, WA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00587392 on ClinicalTrials.gov