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Comparison of Esophageal and Anorectal Manometry Catheters
This study has been terminated.
Sponsors and Collaborators: University of Utah
Clinical Innovations
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00204763
  Purpose

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
Achalasia
Nutcracker Esophagus
Scleroderma
Esophageal Spasm
Fecal Incontinence
Device: Air filled balloon catheter
Device: Solid state catheter
Phase IV

MedlinePlus related topics: Esophagus Disorders Urinary Incontinence
U.S. FDA Resources
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

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
2: Active Comparator
Solid state catheter
Device: Solid state catheter
The standardly used solid state catheter will be tested against the new air filled balloon catheter
A: Experimental Device: Air filled balloon catheter
The new air filled balloon catheter will be tested against the solid state catheter

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 18-80 years old
  • Ability to give informed consent
  • No significant medical conditions
  • Abnormal esophageal motility
  • Abnormal anorectal motility

Exclusion Criteria:

  • Previous esophageal or anorectal surgery, anatomic abnormalities or dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204763

Locations
United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Clinical Innovations
Investigators
Principal Investigator: John C Fang, M.D. University of Utah HSC
  More Information

Publications:
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

Keywords provided by University of Utah:
manometry catheters
diffuse esophageal spasm or hypertensive LES
incontinence

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009