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Healthy volunteers help define 'Normal' for anal function testing

NCT ID NCT06805240

Knowledge-focused Sponsor: Laborie Medical Technologies Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study measured normal anal function in 90 healthy adults aged 18-65. Researchers compared two types of catheters to establish baseline values. The goal was to improve future diagnosis of bowel disorders.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

90 people

The number who actually took part.

Started

Jan 2025

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Healthy male and female adults, 18-65 years old

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • Augusta University Digestive Health Center

    Augusta, Georgia, 30912, United States

  • Digestive Health Center of the Four States, LLC

    Joplin, Missouri, 64804, United States

  • Southwest Gastroenterology

    New Lenox, Illinois, 60451, United States

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