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COMPLETED
NCT06805240

The ILLUMINATE Study

Sponsor: Laborie Medical Technologies Inc.

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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