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Sponsors and Collaborators: |
University of Utah Clinical Innovations |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00204763 |
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.
Condition | Intervention | Phase |
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Achalasia Nutcracker Esophagus Scleroderma Esophageal Spasm Fecal Incontinence |
Device: Air filled balloon catheter Device: Solid state catheter |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters |
Enrollment: | 5 |
Study Start Date: | January 2004 |
Study Completion Date: | April 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
Solid state catheter
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Device: Solid state catheter
The standardly used solid state catheter will be tested against the new air filled balloon catheter
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A: Experimental |
Device: Air filled balloon catheter
The new air filled balloon catheter will be tested against the solid state catheter
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Utah | |
University of Utah HSC | |
Salt Lake City, Utah, United States, 84132 |
Principal Investigator: | John C Fang, M.D. | University of Utah HSC |
Responsible Party: | University of Utah ( University of Utah ) |
Study ID Numbers: | 12127 |
Study First Received: | September 13, 2005 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00204763 |
Health Authority: | United States: Institutional Review Board |
manometry catheters diffuse esophageal spasm or hypertensive LES incontinence |
Spasm Fecal Incontinence Esophageal Spasm, Diffuse Esophageal disorder Gastrointestinal Diseases Urination Disorders Intestinal Diseases Rectal Diseases Cardiospasm |
Achalasia Esophageal Motility Disorders Deglutition Disorders Signs and Symptoms Digestive System Diseases Urologic Diseases Esophageal Achalasia Urinary Incontinence Esophageal Diseases |
Urological Manifestations |