Comparison of Esophageal and Anorectal Manometry Catheters

Tracking Information
First Submitted Date ICMJE	September 13, 2005
First Posted Date ICMJE	September 20, 2005
Last Update Posted Date	January 16, 2008
Study Start Date ICMJE	January 2004
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 20, 2007)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: September 13, 2005)	To compare the accuracy of esophageal and anorectal pressure measurements using air filled balloon catheters
Change History	Complete list of historical versions of study NCT00204763 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Comparison of Esophageal and Anorectal Manometry Catheters
Official Title ICMJE	Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters
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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Achalasia; Nutcracker Esophagus; Scleroderma; Esophageal Spasm; Fecal Incontinence
Intervention ICMJE	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
Study Arms	Active Comparator: 2 Solid state catheter Intervention: Device: Solid state catheter; Experimental: A Intervention: Device: Air filled balloon catheter
Publications *	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.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: January 11, 2008)	5
Original Enrollment ICMJE; (submitted: September 13, 2005)	25
Actual Study Completion Date	April 2007
Actual Primary Completion Date	April 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00204763
Other Study ID Numbers ICMJE	12127
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Utah
Study Sponsor ICMJE	University of Utah
Collaborators ICMJE	Clinical Innovations
Investigators ICMJE	Principal Investigator: John C Fang, M.D. University of Utah HSC
PRS Account	University of Utah
Verification Date	January 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP