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

Completed

• Conditions: Gastroesophageal Reflux Disease (GERD)
• Interventions: Device: NDO Full-thickness Plicator

• Registration Number: NCT00587392
• Lead Sponsor: NDO Surgical, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Last Update Submitted: 2007-12-21
• Study First Posted: 2008-01-07
• Last Update Posted: 2008-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	NDO Full-thickness Plicator	Active NDO Endoscopic Full-thickness Plicator Procedure

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States