Trial Outcomes & Findings for The ILLUMINATE Study (NCT NCT06805240)
NCT ID: NCT06805240
Last Updated: 2026-05-29
Results Overview
Functional anal canal length, cm, as measured by the air charged catheter
Recruitment status
COMPLETED
Target enrollment
90 participants
Primary outcome timeframe
Day 1
Results posted on
2026-05-29
Participant Flow
Participant milestones
| Measure |
Solar Catheter Subjects
Only one ARM/Group was used for this study of subjects using the Laborie Solar Catheter.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The ILLUMINATE Study
Baseline characteristics by cohort
| Measure |
Solar Catheter Subjects
n=81 Participants
Only one ARM/Group was used for this study of subjects using the Laborie Solar Catheter.
|
|---|---|
|
Age, Continuous
|
41.47 years
STANDARD_DEVIATION 12.033 • n=51 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Day 1Functional anal canal length, cm, as measured by the air charged catheter
Outcome measures
| Measure |
Single Arm
n=81 Participants
Only one ARM/Group was used for this study
|
|---|---|
|
Measurement Performance of Air Charged Catheter in cm
|
4.10 cm
Interval 3.838 to 4.153
|
SECONDARY outcome
Timeframe: Day 1Functional anal canal length, cm, as measured by a solid state catheter
Outcome measures
| Measure |
Single Arm
n=81 Participants
Only one ARM/Group was used for this study
|
|---|---|
|
Measurement Performance of Solid State Catheter in cm
|
4.25 cm
Interval 3.851 to 4.483
|
Adverse Events
Solar Catheter Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Project Manager
Laborie Medical Technologies
Phone: (603) 288-1785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER