Trial Outcomes & Findings for VIO Imaging for Skin Tissue Assessment (VISTA) (NCT NCT05619471)

NCT ID: NCT05619471

Last Updated: 2024-07-25

Results Overview

This outcome measured the % agreement and validation of specific tissue features on VIO images in comparison to gold standard pathology images between N=3 Comparative Readers (CRs). "CRs" were study investigators that were selected based on their experience and medical qualifications. 100% agreement and validation between the CRs was required to proceed to the next study phase.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

8 months post-enrollment completion

Results posted on

2024-07-25

Participant Flow

Enrollment Period: 22-Oct-2022 t0 29-Dec-2022

Unit of analysis: 65 lesions

Participant milestones

Participant milestones
Measure	VIO Imaging Skin conditions that are candidates for skin biopsies
Overall Study STARTED	65 65
Overall Study COMPLETED	65 65
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VIO Imaging for Skin Tissue Assessment (VISTA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VIO Imaging n=65 Participants Adult subjects between 18 and 99 years of age willing and able to provide written informed consent either themselves or by their legally authorized representative (LAR) and planning to undergo a routine skin biopsy and adhere to study specific requirements.
Age, Continuous	66 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	65 Participants n=5 Participants
Fitzpatrick Skin Type Type I	6 Participants n=5 Participants
Fitzpatrick Skin Type Type II	18 Participants n=5 Participants
Fitzpatrick Skin Type Type III	27 Participants n=5 Participants
Fitzpatrick Skin Type Type IV	11 Participants n=5 Participants
Fitzpatrick Skin Type Type V	3 Participants n=5 Participants
Fitzpatrick Skin Type Type VI	0 Participants n=5 Participants
Anatomical Location Head and Neck	38 Participants n=5 Participants
Anatomical Location Torso	6 Participants n=5 Participants
Anatomical Location Limbs	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 months post-enrollment completion

Population: Comparative Reader Agreement and Validation was conducted on images taken of all participants

Outcome measures

Outcome measures
Measure	Training Set n=141 Images 141 images from 26 subjects (1 lesion per subject) were selected as Training Set Data to evaluate this primary outcome measure	Validation Set n=248 Images 248 lesions from 39 subjects (1 lesion per subject) were selected as Validation Set Data to evaluate this primary outcome measure
Comparative Reader Percentage Agreement	100 percentage of agreement	100 percentage of agreement

PRIMARY outcome

Timeframe: 8 months post-enrollment completion

This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of VIO images in comparison to the answer key developed from the Comparative Reader validation. "BRs" were study investigators that were selected based on their experience and medical qualifications. \>90% agreement was required to proceed to the next study phase.

Outcome measures

Outcome measures
Measure	Training Set n=450 Questions 141 images from 26 subjects (1 lesion per subject) were selected as Training Set Data to evaluate this primary outcome measure	Validation Set 248 lesions from 39 subjects (1 lesion per subject) were selected as Validation Set Data to evaluate this primary outcome measure
Blinded Reader Percentage Agreement	94 percentage of agreement	—

PRIMARY outcome

Timeframe: 7 +/- 3 days after VIO imaging

Safety will be assessed as the incidence of all adverse events (analyzed by severity, seriousness, and relationship to the device and procedure) that occur through the 7-day follow-up period.

Outcome measures

Outcome measures
Measure	Training Set n=65 Participants 141 images from 26 subjects (1 lesion per subject) were selected as Training Set Data to evaluate this primary outcome measure	Validation Set 248 lesions from 39 subjects (1 lesion per subject) were selected as Validation Set Data to evaluate this primary outcome measure
Safety / Adverse Events	0 adverse events	—

SECONDARY outcome

Timeframe: 8 months post-enrollment completion

This outcome measured the inter-reader % agreement between N=3 Blinded Readers (BRs) during image analysis. Minimum 90% agreement was required to proceed to the next study phase.

Outcome measures

Outcome measures
Measure	Training Set n=450 Questions 141 images from 26 subjects (1 lesion per subject) were selected as Training Set Data to evaluate this primary outcome measure	Validation Set 248 lesions from 39 subjects (1 lesion per subject) were selected as Validation Set Data to evaluate this primary outcome measure
Inter-Reader Percentage Agreement Region	94 percentage of agreement	—
Inter-Reader Percentage Agreement Feature	93 percentage of agreement	—

SECONDARY outcome

Timeframe: 8 months post-enrollment completion

Population: Performance testing on secondary features (Stratum corneum, Hair shaft or follicle, Solar elastosis, Hyperkeratosis, Nodule or nest of cells, Atypia, Epidermal disarray) was conducted using 179 test questions

This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of secondary histopathology characteristics in VIO images in comparison to the answer key developed from the Comparative Reader validation. \>90% agreement was required to proceed to the next study phase.

Outcome measures

Outcome measures
Measure	Training Set n=179 Questions 141 images from 26 subjects (1 lesion per subject) were selected as Training Set Data to evaluate this primary outcome measure	Validation Set 248 lesions from 39 subjects (1 lesion per subject) were selected as Validation Set Data to evaluate this primary outcome measure
Evaluation of Secondary Histopathology Characteristics	98 percentage of agreement	—

Adverse Events

VIO Imaging

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

President

Enspectra Health

Phone: 650 480-6022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Consultant (PI) shall not, either during or subsequent to the Term of the Agreement, directly or indirectly publish any such information (Proprietary Information) without the prior written authorization from Company (Sponsor).
Publication restrictions are in place

Restriction type: OTHER