Comparison of Esophageal and Anorectal Manometry Catheters

Fecal Incontinence Clinical Trial

Official title:

Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00204763
• Other study ID #: 12127
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 11, 2008
• Start date: January 2004
• Est. completion date: April 2007

Study information

• Verified date: January 2008
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Achalasia
• Esophageal Motility Disorders
• Esophageal Spasm
• Esophageal Spasm, Diffuse
• Fecal Incontinence
• Nutcracker Esophagus
• Scleroderma

Intervention

Device:
• Air filled balloon catheter
The new air filled balloon catheter will be tested against the solid state catheter
• Solid state catheter
The standardly used solid state catheter will be tested against the new air filled balloon catheter

Locations

Country	Name	City	State
United States	University of Utah HSC	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Clinical Innovations

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No