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Comparison of Esophageal and Anorectal Manometry Catheters

Sponsor
University of Utah (Other)
Overall Status
Terminated
CT.gov ID
NCT00204763
Collaborator
Clinical Innovations (Industry)
5
Enrollment
1
Location
2
Arms
39
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Air filled balloon catheter
  • Device: Solid state catheter
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2

Solid state catheter

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

Device: Air filled balloon catheter
The new air filled balloon catheter will be tested against the solid state catheter
Other Names:
  • Clinical innovations manometry catheter

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00204763
    Other Study ID Numbers:
    • 12127
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Jan 16, 2008
    Last Verified:
    Jan 1, 2008
    Keywords provided by , ,
    manometry catheters
    diffuse esophageal spasm or hypertensive LES
    incontinence
    Additional relevant MeSH terms:
    Fecal Incontinence
    Esophageal Spasm, Diffuse
    Esophageal Motility Disorders

    Study Results

    No Results Posted as of Jan 16, 2008