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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00575822
Recruitment Status : Terminated (Sponsoring company ceased business operations.)
First Posted : December 18, 2007
Last Update Posted : July 16, 2008
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Device: NDO Full-thickness Plicator Device: Sham Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial
Study Start Date : January 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD

Arm Intervention/treatment
Active Comparator: 1
NDO Endoscopic Full-thickness Plicator procedure
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.
Other Name: Active Plicator procedure

Sham Comparator: 2
Sham control procedure
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.
Other Name: Sham control procedure

Primary Outcome Measures :
  1. >/=50% improvement in GERD-Health Related Quality of Life Score [ Time Frame: 3-months post-procedure ]

Secondary Outcome Measures :
  1. GERD medication use [ Time Frame: 3-months post-procedure ]
  2. Esophageal acid exposure [ Time Frame: 3-months post-procedure ]
  3. Heartburn score as measure by visual analog scale [ Time Frame: 3-months post-procedure ]
  4. Quality of Life as measure by SF-36 [ Time Frame: 3-months post-procedure ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Patients 18 years or older with a history of heartburn or regurgitation symptoms requiring daily PPI therapy were recruited.

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00575822

United States, California
University of California at Irvine Medical Center
Orange, California, United States, 92868
Tri Valley Gastroenterology
San Ramon, California, United States, 94583
United States, Colorado
University of Colorado Health Science Center
Denver, Colorado, United States, 80010
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, New Hampshire
Seacoast Gastroenterology
Exeter, New Hampshire, United States, 03833
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Lenox Hill Hospital
New York, New York, United States, 10021
Columbia University Medical Center
New York, New York, United States, 10032
United States, Tennessee
Nashville Medical Research and the Maria Nathanson Center of Excellence
Nashville, Tennessee, United States, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37240
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Digestive Health Specialists
Tacoma, Washington, United States, 98405
Erasme Hospital
Brussels, Belgium
Klinikum Ludwigsburg, University of Heidelburg
Heidelberg, Germany, 71640
Sponsors and Collaborators
NDO Surgical, Inc.
Principal Investigator: Richard Rothstein, MD Dartmouth-Hitchcock Medical Center, Lebanon, NH
Principal Investigator: Charles Filipi, MD Creighton University Medical Center, Omaha, NE
Principal Investigator: Karel Caca, MD Klinikum Ludwigsburg, University of Heidelburg, Heidelburg, Germany
Principal Investigator: Ronald Pruitt, MD Nashville Medical Research and the Maria Nathanson Center of Excellence, Nashville, TN
Principal Investigator: Klaus Mergener, MD Digestive Health Specialists, Tacoma, WA
Principal Investigator: Alfonso Torquati, MD Vanderbilt University Medical Center, Nashville, TN
Principal Investigator: Gregory Haber, MD Lenox Hill Hospital, New York, NY
Principal Investigator: Yang Chen, MD University of Colorado Health Science Center, Denver, CO
Principal Investigator: Kenneth Chang, MD University of California at Irvine Medical Center, Orange, CA
Principal Investigator: David Wong, MD Tri Valley Gastroenterology, San Ramon, CA
Principal Investigator: Jacques Deviere, MD Erasme Hospital, Brussels, Belgium
Principal Investigator: Douglas Pleskow, MD Beth Israel Deaconess Medical Center, Boston, MA
Principal Investigator: Charles Lightdale, MD Columbia University Medical Center, New York, NY
Principal Investigator: Alain Ades, MD Seacoast Gastroenterology, Exeter, NH
Principal Investigator: Richard Kozarek, MD Virginia Mason Medical Center, Seattle, WA

Publications of Results:
Responsible Party: Bruce R. Gaumond, Associate Director, Clinical Affairs, NDO Surgical, Inc. Identifier: NCT00575822     History of Changes
Other Study ID Numbers: 135-01885
First Posted: December 18, 2007    Key Record Dates
Last Update Posted: July 16, 2008
Last Verified: May 2008

Keywords provided by NDO Surgical, Inc.:
Randomized Controlled Study
Endoscopic Full-thickness Plication

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases