Study Stopped
We determined that the results would not be worth reporting.
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
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2004
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJanuary 16, 2008
January 1, 2008
3.2 years
September 13, 2005
January 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Study Arms (2)
2
ACTIVE COMPARATORSolid state catheter
A
EXPERIMENTALInterventions
The new air filled balloon catheter will be tested against the solid state catheter
The standardly used solid state catheter will be tested against the new air filled balloon catheter
Eligibility Criteria
You may qualify if:
- Between the ages of 18-80 years old
- Ability to give informed consent
- No significant medical conditions
- Abnormal esophageal motility
- Abnormal anorectal motility
You may not qualify if:
- Previous esophageal or anorectal surgery, anatomic abnormalities or dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Clinical Innovationscollaborator
Study Sites (1)
University of Utah HSC
Salt Lake City, Utah, 84132, United States
Related Publications (1)
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.
PMID: 15573923BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John C Fang, M.D.
University of Utah HSC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
January 1, 2004
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
January 16, 2008
Record last verified: 2008-01