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

This study has been terminated.
(Sponsoring company ceased business operations.)
Sponsor:
Information provided by:
NDO Surgical, Inc.
ClinicalTrials.gov Identifier:
NCT00575822
First received: December 14, 2007
Last updated: July 15, 2008
Last verified: May 2008
  Purpose

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 Intervention
Gastroesophageal Reflux Disease (GERD)
Device: NDO Full-thickness Plicator
Device: Sham Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

Resource links provided by NLM:


Further study details as provided by NDO Surgical, Inc.:

Primary Outcome Measures:
  • >/=50% improvement in GERD-Health Related Quality of Life Score [ Time Frame: 3-months post-procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GERD medication use [ Time Frame: 3-months post-procedure ] [ Designated as safety issue: No ]
  • Esophageal acid exposure [ Time Frame: 3-months post-procedure ] [ Designated as safety issue: No ]
  • Heartburn score as measure by visual analog scale [ Time Frame: 3-months post-procedure ] [ Designated as safety issue: No ]
  • Quality of Life as measure by SF-36 [ Time Frame: 3-months post-procedure ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: January 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575822

Locations
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
Columbia University Medical Center
New York, New York, United States, 10032
Lenox Hill Hospital
New York, New York, United States, 10021
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
Belgium
Erasme Hospital
Brussels, Belgium
Germany
Klinikum Ludwigsburg, University of Heidelburg
Heidelberg, Germany, 71640
Sponsors and Collaborators
NDO Surgical, Inc.
Investigators
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
  More Information

Publications:
Responsible Party: Bruce R. Gaumond, Associate Director, Clinical Affairs, NDO Surgical, Inc.
ClinicalTrials.gov Identifier: NCT00575822     History of Changes
Other Study ID Numbers: 135-01885
Study First Received: December 14, 2007
Last Updated: July 15, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014