A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD
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ClinicalTrials.gov Identifier: NCT00575822 |
Recruitment Status
:
Terminated
(Sponsoring company ceased business operations.)
First Posted
: December 18, 2007
Last Update Posted
: July 16, 2008
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Tracking Information | ||||||||||||||||||||||||||||||||||||||||||||||
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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 |
>/=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 |
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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). |
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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 |
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Condition ICMJE | Gastroesophageal Reflux Disease (GERD) | |||||||||||||||||||||||||||||||||||||||||||||
Intervention ICMJE |
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Study Arms |
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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. |
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Recruitment Information | ||||||||||||||||||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Terminated | |||||||||||||||||||||||||||||||||||||||||||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |