Comparison of Esophageal and Anorectal Manometry Catheters
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Achalasia Nutcracker Esophagus Scleroderma Esophageal Spasm Fecal Incontinence |
Device: Air filled balloon catheter Device: Solid state catheter |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Comparison of Solid-State Esophageal Manometry and Water Perfused Anorectal Manometry Catheters With Air Filled Multi-Balloon Esophageal and Anorectal Manometry Catheters |
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | January 2004 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
Solid state catheter
|
Device: Solid state catheter
The standardly used solid state catheter will be tested against the new air filled balloon catheter
|
| Experimental: A |
Device: Air filled balloon catheter
The new air filled balloon catheter will be tested against the solid state catheter
Other Name: Clinical innovations manometry catheter
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Utah | |
| University of Utah HSC | |
| Salt Lake City, Utah, United States, 84132 | |
| Principal Investigator: | John C Fang, M.D. | University of Utah HSC |
More Information
Publications:
| Responsible Party: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT00204763 History of Changes |
| Other Study ID Numbers: | 12127 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 11, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
manometry catheters diffuse esophageal spasm or hypertensive LES incontinence |
Additional relevant MeSH terms:
|
Scleroderma, Systemic Scleroderma, Diffuse Esophageal Achalasia Esophageal Diseases Esophageal Motility Disorders Esophageal Spasm, Diffuse Fecal Incontinence Spasm Connective Tissue Diseases Skin Diseases |
Deglutition Disorders Gastrointestinal Diseases Digestive System Diseases Rectal Diseases Intestinal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013