Clinical trial NCT06805240: EvaluatIng Normal Values for traditionaL anorectaL fUnction paraMeters With aIr Charged aNd Solid State HRAM catheTErs ("ILLUMINATE" Study)
Official title: EvaluatIng Normal Values for traditionaL anorectaL fUnction paraMeters With aIr Charged aNd Solid State HRAM catheTErs ("ILLUMINATE" Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: ARM procedure
ARM measurement
asymptomatic
Healthy
anorectal function
anorectal
Lead sponsor: Laborie Medical Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male and female adults, 18-65 years old

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.

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.

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.

Primary outcomes:
measure: Obtain normative datasets
timeFrame: From Baseline to Day 1
Secondary outcomes:
measure: Qualitatively compare the performance
timeFrame: From Baseline to Day 1
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University Digestive Health Center
state: Georgia
city: New Lenox
country: United States
facility: Southwest Gastroenterology
state: Illinois
city: Joplin
country: United States
facility: Digestive Health Center of the Four States, LLC
state: Missouri
Study officials:
References: