Clinical trial NCT00204763: Comparison of Esophageal and Anorectal Manometry Catheters
Official title: Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Achalasia
Nutcracker Esophagus
Scleroderma
Esophageal Spasm
Fecal Incontinence
Keywords: manometry catheters
diffuse esophageal spasm or hypertensive LES
incontinence
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Clinical Innovations
First posted: 2005-09-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah HSC
state: Utah
Study officials:
affiliation: University of Utah HSC
name: John C Fang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1023/b:ddas.0000043382.59539.d3.