Trial Outcomes & Findings for A Study of a Device Used to Take Pictures of Skin Blood Flow (NCT NCT03912376)
NCT ID: NCT03912376
Last Updated: 2025-12-15
Results Overview
Number of participants evaluated to measure blood flow and oxygenation in the brachial artery
Recruitment status
COMPLETED
Target enrollment
8 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2025-12-15
Participant Flow
Participant milestones
| Measure |
Healthy Volunteer
Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.
Quest Hyperspectral Imaging System: In this camera 3 sensors are combined for optimal spectral imaging. For 2D reference, and to facilitate annotating the data, a high resolution (full HD) color image, recorded with an RGB-sensor, is included with each hyperspectral dataset.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of a Device Used to Take Pictures of Skin Blood Flow
Baseline characteristics by cohort
| Measure |
Healthy Volunteer
n=8 Participants
Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.
Quest Hyperspectral Imaging System: In this camera 3 sensors are combined for optimal spectral imaging. For 2D reference, and to facilitate annotating the data, a high resolution (full HD) color image, recorded with an RGB-sensor, is included with each hyperspectral dataset.
|
|---|---|
|
Age, Continuous
|
23.5 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsNumber of participants evaluated to measure blood flow and oxygenation in the brachial artery
Outcome measures
| Measure |
Healthy Volunteer
n=8 Participants
Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.
Quest Hyperspectral Imaging System: In this camera 3 sensors are combined for optimal spectral imaging. For 2D reference, and to facilitate annotating the data, a high resolution (full HD) color image, recorded with an RGB-sensor, is included with each hyperspectral dataset.
|
|---|---|
|
Number of Participants Evaluated to Measure Blood Flow and Oxygenation in the Brachial Artery
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsMeasure changes in blood flow when vessels constrict or dilate by mean measurements Cutaneous Tissue Oxygen Saturation/StO2
Outcome measures
| Measure |
Healthy Volunteer
n=8 Participants
Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.
Quest Hyperspectral Imaging System: In this camera 3 sensors are combined for optimal spectral imaging. For 2D reference, and to facilitate annotating the data, a high resolution (full HD) color image, recorded with an RGB-sensor, is included with each hyperspectral dataset.
|
|---|---|
|
Mean Cutaneous Tissue Oxygen Saturation/StO2
Basal Phase
|
86.6 percentage of StO2
Standard Deviation 10.0
|
|
Mean Cutaneous Tissue Oxygen Saturation/StO2
Reperfusion
|
85.5 percentage of StO2
Standard Deviation 9.9
|
|
Mean Cutaneous Tissue Oxygen Saturation/StO2
Maximum occlusion
|
72.3 percentage of StO2
Standard Deviation 15.9
|
Adverse Events
Healthy Volunteer
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
Dr. Michelle Bradbury, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 917-294-4585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place