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

NDO Surgical, Inc.33 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

NDO Full-thickness PlicatorDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Cedars Sinai Medical Center

Los Angeles, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Virginia Mason Medical Center

Seattle, Washington, United States

St. Michael's Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

GERD Medication Use

Time frame: 3 and 5-year

Improvement in overall health as measure by the short form Health Survey (SF-36).

Time frame: 3 and 5-year