Comparison of Esophageal and Anorectal Manometry Catheters

This study has been terminated.
(We determined that the results would not be worth reporting.)
Sponsor:
Collaborator:
Clinical Innovations
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00204763
First received: September 13, 2005
Last updated: January 11, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Achalasia
Nutcracker Esophagus
Scleroderma
Esophageal Spasm
Fecal Incontinence
Device: Air filled balloon catheter
Device: Solid state catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters

Resource links provided by NLM:


Further study details as provided by University of Utah:

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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Solid state catheter
Device: Solid state catheter
The standardly used solid state catheter will be tested against the new air filled balloon catheter
Experimental: A 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204763

Locations
United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Clinical Innovations
Investigators
Principal Investigator: John C Fang, M.D. University of Utah HSC
  More Information

Publications:
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00204763     History of Changes
Other Study ID Numbers: 12127
Study First Received: September 13, 2005
Last Updated: January 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
manometry catheters
diffuse esophageal spasm or hypertensive LES
incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Esophageal Motility Disorders
Esophageal Spasm, Diffuse
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Deglutition Disorders
Esophageal Diseases

ClinicalTrials.gov processed this record on October 19, 2014