Comparison of Esophageal and Anorectal Manometry Catheters

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 4

Conditions: Achalasia; Scleroderma; Fecal Incontinence; Esophageal Spasm; Nutcracker Esophagus

Treatments: Device: Solid state catheter; Device: Air filled balloon catheter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00204763

12127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

2

Active Comparator group

Description:

Solid state catheter

Treatment:

Device: Solid state catheter

A

Experimental group

Treatment:

Device: Air filled balloon catheter