Comparison of Esophageal and Anorectal Manometry Catheters
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ClinicalTrials.gov Identifier: NCT00204763 |
Recruitment Status
:
Terminated
(We determined that the results would not be worth reporting.)
First Posted
: September 20, 2005
Last Update Posted
: January 16, 2008
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Tracking Information | ||||
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First Submitted Date ICMJE | September 13, 2005 | |||
First Posted Date ICMJE | September 20, 2005 | |||
Last Update Posted Date | January 16, 2008 | |||
Study Start Date ICMJE | January 2004 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
To compare the accuracy of esophageal and anorectal manometric pressure measurements using a newly developed air filled balloon catheter with present standard solid state esophageal and anorectal catheters [ Time Frame: 6 months ] | |||
Original Primary Outcome Measures ICMJE |
To compare the accuracy of esophageal and anorectal pressure measurements using air filled balloon catheters | |||
Change History | Complete list of historical versions of study NCT00204763 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Comparison of Esophageal and Anorectal Manometry Catheters | |||
Official Title ICMJE | Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters | |||
Brief Summary | The primary objective of this study is to compare the accuracy of esophageal and anorectal manometric pressure measurements using a newly developed air filled balloon catheter with present standard solid state esophageal and anorectal catheters, respectively. | |||
Detailed Description | Twenty subjects with abnormal esophageal motility (5 subjects each with achalasia, nutcracker esophagus, scleroderma, diffuse esophageal spasm or hypertensive LES) previously referred for clinical esophageal motility testing will be contacted. These twenty subjects must have previously undergone esophageal manometry testing using the standard clinical protocol at the University of Utah motility with solid state manometry catheters. After obtaining informed consent, these twenty subjects will undergo the esophageal manometry using air-filled balloon catheters per the standard clinical protocol. Following the repeat procedure a short one-page questionnaire will be completed by the subject and the motility nurse. Five subjects with the diagnosis of incontinence previously referred for clinical anorectal motility testing will be contacted. These five subjects must have previously undergone anorectal manometry using the standard clinical protocol for an anorectal manometry study with water perfused anorectal manometry catheters. After obtaining informed consent, these five subjects will undergo the anorectal manometry using air-filled balloon catheters per the standard clinical protocol. Following the repeat procedure a short one-page questionnaire will be completed by the subject and the motility nurse. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Fang JC, Hilden K, Tuteja AK, Peterson KA. Comparison of air-coupled balloon esophageal and anorectal manometry catheters with solid-state esophageal manometry and water-perfused anorectal manometry catheters. Dig Dis Sci. 2004 Oct;49(10):1657-63. | |||
* 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 |
5 | |||
Original Enrollment ICMJE |
25 | |||
Actual Study Completion Date | April 2007 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00204763 | |||
Other Study ID Numbers ICMJE | 12127 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of Utah | |||
Study Sponsor ICMJE | University of Utah | |||
Collaborators ICMJE | Clinical Innovations | |||
Investigators ICMJE |
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PRS Account | University of Utah | |||
Verification Date | January 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |