Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06805240

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

Led by Laborie Medical Technologies Inc. · Updated on 2025-03-20

81

Participants Needed

3

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female volunteers aged 18 to 65 years
  • Willing to provide informed consent
  • Able and willing to follow instructions for the anorectal manometry procedure
Not Eligible

You will not qualify if you...

  • History of gastrointestinal disorders including fecal incontinence, irritable bowel syndrome, functional constipation, or functional diarrhea as defined by specific symptoms over the past 3 months
  • Use of medications that affect gastrointestinal motility as determined by a healthcare professional
  • Previous pelvic radiation therapy
  • Prior anorectal surgeries, including hemorrhoid treatments
  • Risk factors for pelvic floor trauma such as more than 4 vaginal deliveries, vaginal delivery with birthweight over 4500 grams, known 4th degree perineal tear, or forceps use during delivery
  • Contraindications for anorectal manometry testing
  • Presence of gastrointestinal symptoms indicating need for anorectal manometry
  • Current pregnancy or plans to become pregnant during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Augusta University Digestive Health Center

Augusta, Georgia, United States, 30912

Actively Recruiting

2

Southwest Gastroenterology

New Lenox, Illinois, United States, 60451

Active, Not Recruiting

3

Digestive Health Center of the Four States, LLC

Joplin, Missouri, United States, 64804

Active, Not Recruiting

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Research Team

R

Robert Wroblewski

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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