NCT00587522|Completed
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Sponsor study identifier
interventional
64
2 countries
7
Study Start
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2003
Actual (reported)Study Completion
May 2003
Actual (reported)The purpose of this prospective, multicenter study was to evaluate the safety and efficacy of endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux. Sixty-four patients were enrolled and underwent endoscopic full-thickness plication. All patients received a single implant/plication. No repeat plication procedures were performed. Primary efficacy in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL (Health Related Quality of Life) questionnaire. Secondary efficacy outcomes included post-procedure reduction in anti-secretory therapy, improvement in quality of life questionnaires, reduction in distal esophageal acid exposure, and improvement in esophageal manometry. Patient follow-up assessments were completed at 1, 3, 6 and 12 months post treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2003
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
May 2003
Actual (reported)May 2003
Actual (reported)December 21, 2007
Actual (reported)January 7, 2008
Actual (reported)Percent reduction in GERD symptoms as evidenced by analysis of the GERD-Health Related Quality of Life (HRQL)questionnaire.
3, 6 and 12 months
GERD Medication Use
3, 6 and 12 months
Improvement in Quality of Life Questionnaires (GERD-HRQL, Gastrointestinal Symptom Rating Scale-GSRS and SF-36)
3, 6 and 12 months
Esophageal acid exposure
3 and 6 months
Esophageal manometry
3 months
NDO Full-thickness Plicator Procedure
The Plicator and gastroscope assembly were passed into the stomach. The stomach was distended with air. The gastroscope was advanced and retroflexed so that the instrument could be visualized and accurately positioned. The Plicator was retroflexed to within 1cm below the GE junction, and the helical tissue retractor was advanced deeply into the gastric wall. The gastric wall was retracted into the Plicator instrument arms. The arms were then closed, and the suture-implant was deployed to secure the full-thickness plication. The tissue retractor is then disengaged and the suture-implant released from the instrument.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
St. Michael's Hospital
Toronto, Ontario, M4X1W4, Canada
Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial. Gastrointest Endosc. 2004 Feb;59(2):163-71. doi: 10.1016/s0016-5107(03)02542-2.
Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A. Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc. 2005 May;61(6):643-9. doi: 10.1016/s0016-5107(04)02648-3.
Douglas Pleskow, MD
Beth Israel Deaconess Medical Center
Richard Rothstein, MD
Dartmouth Hitchcock Medical Center, Lebanon, NH
Simon Lo, MD
Cedars Sinai Medical Center, Los Angeles, CA
Robert Hawes, MD
Medical University of South Carolina
64 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2007
First Posted
January 7, 2008
Study Start
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Richard Kozarek, MD
Virginia Mason Medical Center, Seattle, WA
Gregory Haber, MD
St. Michael's Hospital, Toronto, Ontario, Canada
Christopher Gostout, MD
Mayo Clinic, Rochester, MN
Primary Completion
May 2003
Actual (reported)Study Completion
May 2003
Actual (reported)Last Updated
January 7, 2008
Record last verified: 2007-12
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Source: ClinicalTrials.gov.
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