Comparison of Esophageal and Anorectal Manometry Catheters

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Achalasia, Nutcracker Esophagus, Scleroderma, Esophageal Spasm, Fecal Incontinence

Intervention / Treatment
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* Device: Air filled balloon catheter
* Device: Solid state catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Solid state catheter | Device: Solid state catheter<br>* The standardly used solid state catheter will be tested against the new air filled balloon catheter<br>|
| Experimental: A<br> | Device: Air filled balloon catheter<br>* The new air filled balloon catheter will be tested against the solid state catheter<br>* Other names: Clinical innovations manometry catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manometry catheters, diffuse esophageal spasm or hypertensive LES, incontinence