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

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).

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

DEVICE

NDO Full-thickness Plicator

A low-profile (≤6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.

DEVICE

Sham Control

The sham procedure was identical to the treatment procedure through the positioning of the retroflexed Plicator 1cm below the GE junction. The Plicator instrument remained in this position for 15 minutes, based on average procedure times established in previous studies. During the sham procedure, physician investigators were required to talk through the procedure steps to maintain the patient blind.

Sponsors & Collaborators

• NDO Surgical, Inc.

  lead INDUSTRY

Principal Investigators

• Richard Rothstein, MD · Dartmouth-Hitchcock Medical Center, Lebanon, NH

• Charles Filipi, MD · Creighton University Medical Center, Omaha, NE

• Karel Caca, MD · Klinikum Ludwigsburg, University of Heidelburg, Heidelburg, Germany

• Ronald Pruitt, MD · Nashville Medical Research and the Maria Nathanson Center of Excellence, Nashville, TN

• Klaus Mergener, MD · Digestive Health Specialists, Tacoma, WA

• Alfonso Torquati, MD · Vanderbilt University Medical Center, Nashville, TN

• Gregory Haber, MD · Lenox Hill Hospital, New York, NY

• Yang Chen, MD · University of Colorado Health Science Center, Denver, CO

• Kenneth Chang, MD · University of California at Irvine Medical Center, Orange, CA

• David Wong, MD · Tri Valley Gastroenterology, San Ramon, CA

• Jacques Deviere, MD · Erasme Hospital, Brussels, Belgium

• Douglas Pleskow, MD · Beth Israel Deaconess Medical Center, Boston MA

• Charles Lightdale, MD · Columbia University Medical Center, New York, NY

• Alain Ades, MD · Seacoast Gastroenterology, Exeter, NH

• Richard Kozarek, MD · Virginia Mason Medical Center, Seattle, WA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-01-31

Primary Completion

2008-03-31

Completion

2008-03-31

Countries

• United States
• Belgium
• Germany

Study Locations