HealthyILLUMINATENCT06805240

The ILLUMINATE Study

An observational study of Healthy, run by Laborie Medical Technologies Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Air Charged Catheter ARM Procedure and Solid State Catheter ARM Procedure
How many people: 90 participants
Where: 3 sitesUnited States
Study dates: 9 Jan 2025to 23 Apr 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Healthy male and female adults, 18-65 years old

Who may be able to join

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

Who cannot join

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,

Show all 25Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Augusta University Digestive Health Center
Augusta, Georgia, 30912
Digestive Health Center of the Four States, LLC
Joplin, Missouri, 64804
Southwest Gastroenterology
New Lenox, Illinois, 60451

Other trials in United States

About this study

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

Read the detailed 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.

Conditions: Healthy
Being tested: Air Charged Catheter ARM Procedure, Solid State Catheter ARM Procedure
Keywords: ARM procedure, ARM measurement, asymptomatic, Healthy, anorectal function, anorectal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Air Charged Catheter ARM ProcedureDiagnostic test
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.
Solid State Catheter ARM ProcedureDiagnostic test
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement Performance of Air Charged Catheter in cm
Functional anal canal length, cm, as measured by the air charged catheter
Measured: Day 1

Secondary outcomes (1)

Measurement Performance of Solid State Catheter in cm
Functional anal canal length, cm, as measured by a solid state catheter
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 202523 Apr 2025

First posted3 Feb 2025
Study start9 Jan 2025
Primary completion23 Apr 2025
Study completion23 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06805240
Sponsor's protocol ID: CLN-00043
Other IDs: Solar-01
Acronym: ILLUMINATE
Status last verified: Mar 2025
First submitted: 24 Jan 2025
Last updated: 29 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
RecruitingPhase 1
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Healthy
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EvaluatIng Normal Values for traditionaL anorectaL fUnction paraMeters With aIr Charged aNd Solid State HRAM catheTErs ("ILLUMINATE" Study)
ClinicalTrials.gov ID: NCT06805240
Acronym / sponsor ID: ILLUMINATE / CLN-00043
Conditions: Healthy
Keywords: ARM procedure, ARM measurement, asymptomatic, Healthy, anorectal function, anorectal
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Laborie Medical Technologies Inc.Industry (pharma, biotech, devices)
Study start: 9 Jan 2025 (actual)
Primary completion: 23 Apr 2025 (actual)
Study completion: 23 Apr 2025 (actual)
First posted: 3 Feb 2025 (actual)
Results: Posted 29 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Healthy male and female adults, 18-65 years old

Key inclusion criteria (3 listed)

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

Key exclusion criteria (25 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Air Charged Catheter ARM ProcedureNormative 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 test	–
Solid State Catheter ARM ProcedureNormative 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.	Diagnostic test	–

Primary outcome

Measurement Performance of Air Charged Catheter in cm
Time frame: Day 1
Functional anal canal length, cm, as measured by the air charged catheter

1 secondary outcome

Measurement Performance of Solid State Catheter in cm
Time frame: Day 1

Results and safety

Results posted to the registry on 29 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solar Catheter Subjects	90	81

Primary outcome: Measurement Performance of Air Charged Catheter in cm

Time frame: Day 1. Median (95% Confidence Interval). Unit: cm

Measure	Single Arm n = 81
Value	4.10 (3.838 to 4.153)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment until study exit on day 1 visit. However, if an AE occurs and is unresolved during the study visit, a follow-up will occur through 30 days post-procedure or until resolution, whichever is earlier.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solar Catheter Subjects	0 of 81 (0%)	0 of 81 (0%)	0 of 81

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
RecruitingPhase 1
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Healthy
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Laborie Medical Technologies Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement Performance of Air Charged Catheter in cm (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06805240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.