EvaluatIng Normal Values for TraditionaL AnorectaL FUnction ParaMeters with AIr Charged and Solid State HRAM CatheTErs ("ILLUMINATE" Study)

Description

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

Healthy

Study Overview

Study Details

Study 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.

EvaluatIng Normal Values for TraditionaL AnorectaL FUnction ParaMeters with AIr Charged and Solid State HRAM CatheTErs ("ILLUMINATE" Study)

EvaluatIng Normal Values for TraditionaL AnorectaL FUnction ParaMeters with AIr Charged and Solid State HRAM CatheTErs ("ILLUMINATE" Study)

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

New Lenox

Southwest Gastroenterology, New Lenox, Illinois, United States, 60451

Joplin

Digestive Health Center of the Four States, LLC, Joplin, Missouri, United States, 64804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 1. Documented history of gastrointestinal disorders such as:
  • 3. Prior pelvic radiation, 4. Prior anorectal surgical procedures, including treatment for hemorrhoids, 5. Risk factors for pelvic floor trauma:
  • 1. more than 4 vaginal deliveries,
  • 2. vaginal delivery with birthweight greater than 4500gms (macrosomia),
  • 3. 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Laborie Medical Technologies Inc.,

Study Record Dates

2026-01