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

NCT06805240 | Recruiting FDA Device

• 2 other identifiers: CLN-00043Solar-01
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Keywords

ARM procedure; ARM measurement; asymptomatic; Healthy; anorectal function; anorectal

Outcome Measures

Primary Outcomes (1)

• Obtain normative datasets

  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.

  From Baseline to Day 1

Secondary Outcomes (1)

• Qualitatively compare the performance

  From Baseline to Day 1

Interventions

Air Charged Catheter ARM Procedure DIAGNOSTIC_TEST

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.

Solid State Catheter ARM Procedure DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female adults, 18-65 years old

You may qualify if:

• \. Male and female volunteers, 18-65 years old
• \. Willing to provide informed consent
• \. Willing and able to follow instructions for ARM procedure

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Laborie Medical Technologies Inc.: lead

Study Sites (3)

Augusta University Digestive Health Center

Augusta, Georgia, 30912, United States

RECRUITING

Southwest Gastroenterology

New Lenox, Illinois, 60451, United States

ACTIVE NOT RECRUITING

Digestive Health Center of the Four States, LLC

Joplin, Missouri, 64804, United States

ACTIVE NOT RECRUITING

Central Study Contacts

Robert Wroblewski

CONTACT

+1 (603) 288-1785; rwroblewski@laborie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 3, 2025
• Study Start: January 9, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (3)