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The ILLUMINATE Study
Sponsor: Laborie Medical Technologies Inc.
Summary
The research study will be conducted to obtain baseline, or "normative" information to compare an air charged HRAM catheter to traditional solid catheter measures using the IAPWG standardized testing protocol and London classification.
Official title: EvaluatIng Normal Values for traditionaL anorectaL fUnction paraMeters With aIr Charged aNd Solid State HRAM catheTErs ("ILLUMINATE" Study)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
90
Start Date
2025-01-09
Completion Date
2025-04-23
Last Updated
2026-05-29
Healthy Volunteers
Yes
Conditions
Interventions
Air Charged Catheter ARM Procedure
Normative datasets for traditional measures of anorectal function with an air charged HRAM catheter will be collected in healthy subjects using the IAPWG standardized testing protocol and London classification for ARM measurement.
Solid State Catheter ARM Procedure
Normative datasets for traditional measures of anorectal function with a solid state HRAM catheter will be collected in some healthy subjects using the IAPWG standardized testing protocol and London classification for ARM measurement for comparison to the air charged catheter.
Locations (3)
Augusta University Digestive Health Center
Augusta, Georgia, United States
Southwest Gastroenterology
New Lenox, Illinois, United States
Digestive Health Center of the Four States, LLC
Joplin, Missouri, United States