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Comparison of Esophageal and Anorectal Manometry Catheters

This study has been terminated.
(We determined that the results would not be worth reporting.)
Sponsor:
Collaborator:
Clinical Innovations
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00204763
First received: September 13, 2005
Last updated: January 11, 2008
Last verified: January 2008

September 13, 2005
January 11, 2008
January 2004
April 2007   (final data collection date for primary outcome measure)
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 ]
To compare the accuracy of esophageal and anorectal pressure measurements using air filled balloon catheters
Complete list of historical versions of study NCT00204763 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Esophageal and Anorectal Manometry Catheters
Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Achalasia
  • Nutcracker Esophagus
  • Scleroderma
  • Esophageal Spasm
  • Fecal Incontinence
  • Device: Air filled balloon catheter
    The new air filled balloon catheter will be tested against the solid state catheter
    Other Name: Clinical innovations manometry catheter
  • Device: Solid state catheter
    The standardly used solid state catheter will be tested against the new air filled balloon catheter
  • Active Comparator: 2
    Solid state catheter
    Intervention: Device: Solid state catheter
  • Experimental: A
    Intervention: Device: Air filled balloon catheter
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.
 
Terminated
5
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00204763
12127
No
University of Utah
University of Utah
Clinical Innovations
Principal Investigator: John C Fang, M.D. University of Utah HSC
University of Utah
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP