Comparison of Esophageal and Anorectal Manometry Catheters - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

January 11, 2008

Start Date ^ICMJE

January 2004

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Achalasia
Nutcracker Esophagus
Scleroderma
Esophageal Spasm
Fecal Incontinence

Intervention ^ICMJE

Device: Air filled balloon catheter
Device: Solid state catheter

Study Arms / Comparison Groups

Active Comparator: Solid state 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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2007

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00204763

Responsible Party

University of Utah, University of Utah

Study ID Numbers ^ICMJE

12127

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Clinical Innovations

Investigators ^ICMJE

Principal Investigator:

John C Fang, M.D.

University of Utah HSC

Information Provided By

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