The ILLUMINATE Study

Laborie Medical Technologies Inc.90 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy

Interventions

Air Charged Catheter ARM ProcedureDIAGNOSTIC_TEST

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 ProcedureDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

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

Outcomes

Primary Outcomes

Measurement Performance of Air Charged Catheter in cm

Functional anal canal length, cm, as measured by the air charged catheter

Time frame: Day 1

Secondary Outcomes

Measurement Performance of Solid State Catheter in cm

Functional anal canal length, cm, as measured by a solid state catheter

Time frame: Day 1

Data from ClinicalTrials.gov

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