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

Tracking Information
First Submitted Date ICMJE	December 14, 2007
First Posted Date ICMJE	December 18, 2007
Last Update Posted Date	July 16, 2008
Study Start Date ICMJE	January 2005
Actual Primary Completion Date	March 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 17, 2007)	>/=50% improvement in GERD-Health Related Quality of Life Score [ Time Frame: 3-months post-procedure ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00575822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 17, 2007)	GERD medication use [ Time Frame: 3-months post-procedure ]; Esophageal acid exposure [ Time Frame: 3-months post-procedure ]; Heartburn score as measure by visual analog scale [ Time Frame: 3-months post-procedure ]; Quality of Life as measure by SF-36 [ Time Frame: 3-months post-procedure ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD
Official Title ICMJE	Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial
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).
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Gastroesophageal Reflux Disease (GERD)
Intervention ICMJE	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; 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
Study Arms	Active Comparator: 1 NDO Endoscopic Full-thickness Plicator procedure Intervention: Device: NDO Full-thickness Plicator; Sham Comparator: 2 Sham control procedure Intervention: Device: Sham Control
Publications *	Rothstein R, Filipi C, Caca K, Pruitt R, Mergener K, Torquati A, Haber G, Chen Y, Chang K, Wong D, Deviere J, Pleskow D, Lightdale C, Ades A, Kozarek R, Richards W, Lembo A. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial. Gastroenterology. 2006 Sep;131(3):704-12.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: December 17, 2007)	159
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2008
Actual Primary Completion Date	March 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Germany, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00575822
Other Study ID Numbers ICMJE	135-01885
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bruce R. Gaumond, Associate Director, Clinical Affairs, NDO Surgical, Inc.
Study Sponsor ICMJE	NDO Surgical, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	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
PRS Account	NDO Surgical, Inc.
Verification Date	May 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP