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Clinical Trial NCT06805240 (ILLUMINATE) for Healthy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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EvaluatIng Normal Values for traditionaL anorectaL fUnction paraMeters With aIr Charged aNd Solid State HRAM catheTErs ("ILLUMINATE" Study) 81

Recruiting
Clinical Trial NCT06805240 (ILLUMINATE) is an observational study for Healthy that is recruiting. It started on 9 January 2025 with plans to enroll 81 participants. Led by Laborie Medical Technologies Inc., it is expected to complete by 1 January 2026. The latest data from ClinicalTrials.gov was last updated on 20 March 2025.
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 val...

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Official Title

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

Conditions
Healthy
Other Study IDs
  • ILLUMINATE
  • CLN-00043
  • Solar-01 (Other Identifier) (Laborie Medical Technologies Corporation)
NCT ID Number
NCT06805240
Start Date (Actual)
2025-01-09
Last Update Posted
2025-03-20
Completion Date (Estimated)
2026-01
Enrollment (Estimated)
81
Study Type
Observational
Status
Recruiting
Keywords
ARM procedure
ARM measurement
asymptomatic
Healthy
anorectal function
anorectal
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
Air Charged Catheter ARM Procedure
Normative datasets for traditional measures of anorectal function with an air charged HRAM catheter will be collected in healthy subjects using the IAPWG standardized testing protocol and London classification for ARM measurement.
Solid State Catheter ARM Procedure
Normative datasets for traditional measures of anorectal function with a solid state HRAM catheter will be collected in some healthy subjects using the IAPWG standardized testing protocol and London classification for ARM measurement for comparison to the air charged catheter.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Obtain normative datasets
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 ARM measurement.
From Baseline to Day 1
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Qualitatively compare the performance
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.
From Baseline to Day 1
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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.
Laborie Medical Technologies Inc. logoLaborie Medical Technologies Inc.
Study Central Contact
Contact: Robert Wroblewski, +1 (603) 288-1785, [email protected]
3 Study Locations in 1 Countries

Georgia

Augusta University Digestive Health Center, Augusta, Georgia, 30912, United States
Research Assistant, Contact, 706-721-1968, [email protected]
Satish Rao, MD, PhD, FRCP (LON), FACG AGAF, Principal Investigator
Recruiting

Illinois

Southwest Gastroenterology, New Lenox, Illinois, 60451, United States
Active, not recruiting

Missouri

Digestive Health Center of the Four States, LLC, Joplin, Missouri, 64804, United States
Active, not recruiting