Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204763
Status:
TERMINATED
Last Update Posted:
2008-01-16
First Post:
2005-09-13
Brief Title:
Comparison of Esophageal and Anorectal Manometry Catheters
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters
Status:
TERMINATED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We determined that the results would not be worth reporting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None