The ILLUMINATE Study

Completed

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT06805240

Run by

Laborie Medical Technologies Inc.

People needed

90

Starts

2025-01-09

Expected to finish

2025-04-23

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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