N/A
N=90
The ILLUMINATE Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT06805240 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Measurement Performance of Air Charged Catheter in cm — 4.10 cm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Air Charged Catheter ARM Procedure (Diagnostic_test); Solid State Catheter ARM Procedure (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laborie Medical Technologies Inc.
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement Performance of Air Charged Catheter in cm |
4.10 | — |
| SECONDARY Measurement Performance of Solid State Catheter in cm |
4.25 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT06805240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.