Comparison of Esophageal and Anorectal Manometry Catheters
Primary Purpose
Achalasia, Nutcracker Esophagus, Scleroderma
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Air filled balloon catheter
Solid state catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Achalasia focused on measuring manometry catheters, diffuse esophageal spasm or hypertensive LES, incontinence
Eligibility 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
Sites / Locations
- University of Utah HSC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2
A
Arm Description
Solid state catheter
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00204763
First Posted
September 13, 2005
Last Updated
January 11, 2008
Sponsor
University of Utah
Collaborators
Clinical Innovations
1. Study Identification
Unique Protocol Identification Number
NCT00204763
Brief Title
Comparison of Esophageal and Anorectal Manometry Catheters
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 Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Why Stopped
We determined that the results would not be worth reporting.
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Utah
Collaborators
Clinical Innovations
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achalasia, Nutcracker Esophagus, Scleroderma, Esophageal Spasm, Fecal Incontinence
Keywords
manometry catheters, diffuse esophageal spasm or hypertensive LES, incontinence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Solid state catheter
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Air filled balloon catheter
Other Intervention Name(s)
Clinical innovations manometry catheter
Intervention Description
The new air filled balloon catheter will be tested against the solid state catheter
Intervention Type
Device
Intervention Name(s)
Solid state catheter
Intervention Description
The standardly used solid state catheter will be tested against the new air filled balloon catheter
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Fang, M.D.
Organizational Affiliation
University of Utah HSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah HSC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15573923
Citation
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. doi: 10.1023/b:ddas.0000043382.59539.d3.
Results Reference
background
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Comparison of Esophageal and Anorectal Manometry Catheters
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