A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD

Stopped early · Not applicable · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

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).

Key facts

Study ID

NCT00575822

Run by

NDO Surgical, Inc.

People needed

159

Starts

2005-01-01

Expected to finish

2008-03-01

Last updated by the study team

2008-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of California at Irvine Medical Center — Orange, California, United States
• Tri Valley Gastroenterology — San Ramon, California, United States
• University of Colorado Health Science Center — Denver, Colorado, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Creighton University Medical Center — Omaha, Nebraska, United States
• Seacoast Gastroenterology — Exeter, New Hampshire, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Lenox Hill Hospital — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Nashville Medical Research and the Maria Nathanson Center of Excellence — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Digestive Health Specialists — Tacoma, Washington, United States
• Erasme Hospital — Brussels, Belgium
• Klinikum Ludwigsburg, University of Heidelburg — Heidelberg, Germany

Full record on ClinicalTrials.gov

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