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

December 21, 2007 updated by: NDO Surgical, Inc.
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4X1W4
        • St. Michael's Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria (required prior to original treatment):

  • History of heartburn or regurgitation for at least 6-months requiring maintenance daily anti-secretory therapy;
  • esophageal manometry study demonstrating peristaltic amplitude >35mmHg and LES resting pressure >/=5mmHg;
  • Increased esophageal acid exposure demonstrated through a 24-hour pH study.

Exclusion Criteria (required prior to original treatment):

  • Erosive esophagitis (Savary-Miller grade III or IV);
  • Barrett's esophagus;
  • Esophageal stricture;
  • Hiatal hernia >2cm;
  • Persistent dysphagia, weight loss, esophageal bleeding, vomiting or gas-bloat
  • Esophageal or gastric varices;
  • Use of anticoagulants other than for cardiac prophylaxis
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Active NDO Endoscopic Full-thickness Plicator Procedure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of GERD symptoms through analysis of GERD-Health Related Quality of Life (HRQL) questionnaire and Gastrointestinal Symptom Rating Scale (GSRS).
Time Frame: 3 and 5-years
3 and 5-years

Secondary Outcome Measures

Outcome Measure
Time Frame
GERD Medication Use
Time Frame: 3 and 5-year
3 and 5-year
Improvement in overall health as measure by the short form Health Survey (SF-36).
Time Frame: 3 and 5-year
3 and 5-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NDO Surgical, Inc.

Investigators

  • 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
  • Principal Investigator: Norman Marcon, MD, St. Michael's Hospital, Toronto, Ontario, Canada
  • Principal Investigator: Richard Kozarek, MD, Virginia Mason Medical Center, Seattle, WA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 7, 2008

Study Record Updates

Last Update Posted (Estimate)

January 7, 2008

Last Update Submitted That Met QC Criteria

December 21, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135-01928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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