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

NCT06805240 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • Laborie Medical Technologies Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06805240 on ClinicalTrials.gov