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| Sponsored by: |
NDO Surgical, Inc. |
|---|---|
| Information provided by: | NDO Surgical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00575822 |
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: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial |
| 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 |
|---|---|
|
1: Active Comparator
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.
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2: Sham Comparator
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. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
Exclusion Criteria:
Contacts and 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 | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| Seacoast Gastroenterology | |
| Exeter, New Hampshire, United States, 03833 | |
| 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 | |
| Digestive Health Specialists | |
| Tacoma, Washington, United States, 98405 | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Belgium | |
| Erasme Hospital | |
| Brussels, Belgium | |
| Germany | |
| Klinikum Ludwigsburg, University of Heidelburg | |
| Heidelberg, Germany, 71640 | |
| 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
| Responsible Party: | NDO Surgical, Inc. ( Bruce R. Gaumond, Associate Director, Clinical Affairs ) |
| Study ID Numbers: | 135-01885 |
| Study First Received: | December 14, 2007 |
| Last Updated: | July 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00575822 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
GERD Sham Randomized Controlled Study Endoscopic Full-thickness Plication Plicator |
|
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Benzocaine Esophageal Diseases Gastroesophageal Reflux |
|
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases |
Gastrointestinal Diseases Esophageal Diseases Gastroesophageal Reflux |
