EvaluatIng Normal Values for TraditionaL AnorectaL FUnction ParaMeters with AIr Charged and Solid State HRAM CatheTErs ("ILLUMINATE" Study)

Recruiting

• Conditions: Healthy

• Registration Number: NCT06805240
• Lead Sponsor: Laborie Medical Technologies Inc.

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.

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.

Study Timeline

• Study Start: 2025-01-09
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 81

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 by healthcare professional.
• 3. Prior pelvic radiation,
• 4. Prior anorectal surgical procedures, including treatment for hemorrhoids,
• 5. Risk factors for pelvic floor trauma:
• a. more than 4 vaginal deliveries,
• b. vaginal delivery with birthweight greater than 4500gms (macrosomia),
• c. known 4th degree perineal tear or known forceps use during delivery.
• 6. Contraindicated for ARM testing
• 7. Has gastrointestinal symptoms and is indicated for ARM testing
• 8. Subject is currently pregnant or plans to become pregnant during the course of their enrollment in the study, as self-reported.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obtain normative datasets	From Baseline to Day 1	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 ARM measurement.

Secondary Outcome Measures

Name	Time	Method
Qualitatively compare the performance	From Baseline to Day 1	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.

Trial Locations

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