A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Interventions
- Device: NDO Full-thickness PlicatorDevice: Sham Control
- Registration Number
- NCT00575822
- Lead Sponsor
- NDO Surgical, Inc.
- Brief Summary
The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure.
Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure.
Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 159
- GERD-HRQL score ≥ 15 while off PPI therapy, and at least 6 points higher than on-PPI score
- Pathologic esophageal acid exposure, defined as pH<4.0 ≥ 4.5% of a 24- or 48-hour monitoring period or a DeMeester score > 14.7
- Lower esophageal resting pressure of at least 5mmHg; and
- Suitability for surgery (American Society of Anesthesiologists Physical Status Classification I or II).
- Significant esophageal dysmotility as determined by manometry
- Esophagitis grade III or IV (Savary-Miller)
- Barrett's epithelium
- Hiatus hernia > 2cm
- Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
- Esophageal or gastric varices
- Previous endoscopic or surgical anti-reflux procedure
- Other esophageal or gastric surgery
- Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 NDO Full-thickness Plicator NDO Endoscopic Full-thickness Plicator procedure 2 Sham Control Sham control procedure
- Primary Outcome Measures
Name Time Method >/=50% improvement in GERD-Health Related Quality of Life Score 3-months post-procedure
- Secondary Outcome Measures
Name Time Method GERD medication use 3-months post-procedure Esophageal acid exposure 3-months post-procedure Heartburn score as measure by visual analog scale 3-months post-procedure Quality of Life as measure by SF-36 3-months post-procedure
Trial Locations
- Locations (15)
Tri Valley Gastroenterology
🇺🇸San Ramon, California, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
University of California at Irvine Medical Center
🇺🇸Orange, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Colorado Health Science Center
🇺🇸Denver, Colorado, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Seacoast Gastroenterology
🇺🇸Exeter, New Hampshire, United States
Digestive Health Specialists
🇺🇸Tacoma, Washington, United States
Erasme Hospital
🇧🇪Brussels, Belgium
Nashville Medical Research and the Maria Nathanson Center of Excellence
🇺🇸Nashville, Tennessee, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Klinikum Ludwigsburg, University of Heidelburg
🇩🇪Heidelberg, Germany