RECRUITING

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

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Conditions

HealthyARM procedureARM measurementasymptomaticanorectal functionanorectal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-09
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06805240

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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. * 1. Documented history of gastrointestinal disorders such as:
  2. 3. Prior pelvic radiation, 4. Prior anorectal surgical procedures, including treatment for hemorrhoids, 5. Risk factors for pelvic floor trauma:
  3. 1. more than 4 vaginal deliveries,
  4. 2. vaginal delivery with birthweight greater than 4500gms (macrosomia),
  5. 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.

Contacts and Locations

Study Contact

Robert Wroblewski
CONTACT
+1 (603) 288-1785
rwroblewski@laborie.com

Study Locations (Sites)

Southwest Gastroenterology
New Lenox, Illinois, 60451
United States
Digestive Health Center of the Four States, LLC
Joplin, Missouri, 64804
United States

Collaborators and Investigators

Sponsor: Laborie Medical Technologies Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-09
Study Completion Date2026-01

Study Record Updates

Study Start Date2025-01-09
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • ARM procedure
  • ARM measurement
  • asymptomatic
  • Healthy
  • anorectal function
  • anorectal

Additional Relevant MeSH Terms

  • Healthy