The ILLUMINATE Study (ILLUMINATE)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Air Charged Catheter ARM Procedure; Diagnostic test: Solid State Catheter ARM Procedure

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 Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Digestive Health Center
  • Illinois
    • New Lenox, Illinois, United States, 60451
      • Southwest Gastroenterology
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Digestive Health Center of the Four States, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female adults, 18-65 years old

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement Performance of Air Charged Catheter in cm	Functional anal canal length, cm, as measured by the air charged catheter	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement Performance of Solid State Catheter in cm	Functional anal canal length, cm, as measured by a solid state catheter	Day 1

Collaborators and Investigators

• Sponsor: Laborie Medical Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Actual): April 23, 2025
• Study Completion (Actual): April 23, 2025

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Healthy; asymptomatic; anorectal function; anorectal; ARM procedure; ARM measurement
• Other Study ID Numbers: CLN-00043; Solar-01 (Other Identifier: Laborie Medical Technologies Corporation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No