← Back to Clinical Trials
RecruitingNCT06805240

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

Trial Parameters

ConditionHealthy
SponsorLaborie Medical Technologies Inc.
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment81
SexALL
Min Age18 Years
Max Age65 Years
Start Date2025-01-09
Completion2026-01
Interventions
Air Charged Catheter ARM ProcedureSolid State Catheter ARM Procedure

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 1\. Male and female volunteers, 18-65 years old * 2\. Willing to provide informed consent * 3\. Willing and able to follow instructions for ARM procedure Exclusion Criteria: * 1\. Documented history of gastrointestinal disorders such as: * a. fecal incontinence, * b. irritable bowel syndrome (IBS), * c. functional constipation, as defined by two or more of these symptoms for at least 25% of the time over the past 3 months: * i. excessive straining, * ii. hard or lumpy stools, * iii. sensation of incomplete evacuation, * iv. a feeling of anorectal blockage, * v. manual maneuvers to facilitate defecation, * vi. or fewer than 3 bowel movements per week. * d. functional diarrhea, as defined by the following symptoms over the past 3 months: * i. Loose or watery stools * ii. Lack of pain with diarrhea * iii. Diarrhea occurring in at least 75% of bowel movements * iv. No identifiable causes * 2\. Use of medications that may affect gastrointestinal motility as determined

Related Trials