Trial Outcomes & Findings for Non-Linear Imaging of Skin In Vivo (NCT NCT05410964)
NCT ID: NCT05410964
Last Updated: 2024-01-30
Results Overview
Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality.
COMPLETED
122 participants
3 hours
2024-01-30
Participant Flow
Participant milestones
| Measure |
VIO Imaging
Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics
|
|---|---|
|
Overall Study
STARTED
|
122
|
|
Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Linear Imaging of Skin In Vivo
Baseline characteristics by cohort
| Measure |
VIO Imaging
n=122 Participants
Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics
|
|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 19 • n=99 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type I
|
6 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type II
|
30 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type III
|
46 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
25 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type V
|
5 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
1 Participants
n=99 Participants
|
|
Fitzpatrick Skin Type
Unknown
|
9 Participants
n=99 Participants
|
|
Skin Health
Healthy
|
90 Participants
n=99 Participants
|
|
Skin Health
Suspected or known skin diseases
|
32 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 hoursPopulation: VIO System Imaging Performance assessment was conducted on images taken of all participants
Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality.
Outcome measures
| Measure |
VIO Imaging
n=122 Participants
Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics
|
|---|---|
|
VIO System Imaging Performance
|
122 # participants with acceptable images
|
PRIMARY outcome
Timeframe: 3 hoursPopulation: VIO System Image Quality assessment was conducted on images taken of all participants
Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device image quality (acceptable/not acceptable) was assessed through clinical expert review of VIO images. The clinical expert review determined whether VIO images could be interpreted by physicians trained in dermatopathology.
Outcome measures
| Measure |
VIO Imaging
n=122 Participants
Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics
|
|---|---|
|
VIO System Image Quality
|
122 # participants with acceptable images
|
Adverse Events
VIO Imaging
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