Trial Outcomes & Findings for Image Guidance for Improved Vessel Cannulation in Pediatric Patients (NCT NCT04031495)
NCT ID: NCT04031495
Last Updated: 2026-07-30
Results Overview
device enabled successful cannulation on the first pass showing feasibility to aid in cvcs
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
1 day
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
Vessel Cannulation With Scenergy
Patients who were cannulated with the assistance of the Scenergy guidance device
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Image Guidance for Improved Vessel Cannulation in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Vessel Cannulation With Scenergy
n=9 Participants
Patients who were cannulated with the assistance of the Scenergy guidance device
|
|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 3.5 • n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 1 daydevice enabled successful cannulation on the first pass showing feasibility to aid in cvcs
Outcome measures
| Measure |
Vessel Cannulation With Scenergy
n=9 Participants
Patients who were cannulated with the assistance of the Scenergy guidance device
|
|---|---|
|
Successful Central Vein Cannulation
|
9 Participants
|
Adverse Events
Vessel Cannulation With Scenergy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place