NCT06805240

EvaluatIng Normal Values for traditionaL anorectaL fUnction paraMeters With aIr Charged aNd Solid State HRAM catheTErs ("ILLUMINATE" Study)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 81 (estimated)
• Sponsor: Laborie Medical Technologies Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary purpose of this research study is to obtain normative datasets for traditional measures of anorectal function with an air charged HRAM catheter in healthy subjects using the IAPWG standardized testing protocol and London classification for anorectal manometry (ARM) measurement. A secondary purpose is to qualitatively compare the performance of air charged and solid state HRAM catheters in determining values for traditional measures of anorectal function in a subset of study subjects using the IAPWG standardized testing protocol and London classification for ARM measurement.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-09
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-02-03
• Last updated: 2025-03-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study