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

Launched by LABORIE MEDICAL TECHNOLOGIES INC. · Jan 29, 2025

Keywords

ClinConnect Summary

The ILLUMINATE study is a research trial designed to gather important information about how healthy people normally function in terms of their anorectal (the area around the anus and rectum) health. Specifically, it will compare two types of catheters—one that uses air and one that is solid—to see how they measure and assess this function. The goal is to establish baseline values that can help doctors understand what is normal for patients, using standardized testing methods.

If you are a healthy adult aged 18 to 65 and are interested in participating, you may be eligible for the study. However, certain medical conditions, like gastrointestinal disorders or a history of specific surgeries, may prevent you from joining. Participants in the trial can expect to follow specific instructions during the procedure and will help researchers gain valuable insights into anorectal health. This information could ultimately lead to better care and understanding for patients with related health issues in the future.

Gender

ALL

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.