Comparison of Esophageal and Anorectal Manometry Catheters

Phase 4

Terminated

• Conditions: Achalasia; Nutcracker Esophagus; Scleroderma; Esophageal Spasm; Fecal Incontinence
• Interventions: Device: Solid state catheter; Device: Air filled balloon catheter

• Registration Number: NCT00204763
• Lead Sponsor: University of Utah

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 Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-11
• Last Update Posted: 2008-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Solid state catheter	Solid state catheter
A	Air filled balloon catheter	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Utah HSC; 🇺🇸 Salt Lake City, Utah, United States