EvaluatIng Normal Values for traditionaL anorectaL fUnction paraMeters With aIr Charged aNd Solid State HRAM catheTErs ("ILLUMINATE" Study)
Laborie Medical Technologies Inc.
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.
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
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- Diagnostic TestAir 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.
- Diagnostic TestSolid 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.
Locations (3)
- Augusta University Digestive Health CenterAugusta, Georgia
- Southwest GastroenterologyNew Lenox, Illinois
- Digestive Health Center of the Four States, LLCJoplin, Missouri