An interventional study of VIO Imaging in Skin Condition, Skin Diseases and Skin Lesion, sponsored by Enspectra Health. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Enspectra Health · Not applicable, Interventional, and Diagnostic
To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment.
To demonstrate that the tissue features identified on the images obtained with the VIO device align with the corresponding pathology images procured from the skin biopsy.
To evaluate the ability of blinded readers to correctly identify tissue features on images obtained with the VIO device.
496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.
This study's enrollment of 65 is close to the median of 70 across 375 interventional studies indexed under Skin Diseases.
Browse Skin Diseases studies →Enspectra Health is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The subject's lesion targeted for :
Is located in the periorbital region or directly on the eyelid.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with skin conditions that are candidates for biopsy
Device: VIO Imaging
Skin conditions that are candidates for skin biopsies
Comparative Reader Percentage Agreement
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.
Time frame: 8 months post-enrollment completion
Blinded Reader Percentage Agreement
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.
Time frame: 8 months post-enrollment completion
Safety / Adverse Events
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.
Time frame: 7 +/- 3 days after VIO imaging
Inter-Reader Percentage Agreement
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.
Time frame: 8 months post-enrollment completion
Evaluation of Secondary Histopathology Characteristics
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.
Time frame: 8 months post-enrollment completion
Enrollment Period: 22-Oct-2022 t0 29-Dec-2022
| Milestone | VIO Imaging |
|---|---|
| Started | 65 |
| Completed | 65 |
| Not completed | 0 |
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.
| percentage of agreement | Training Set | Validation Set |
|---|---|---|
| Comparative Reader Percentage Agreement | 100 | 100 |
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.
| percentage of agreement | Performance Test |
|---|---|
| Blinded Reader Percentage Agreement | 94 |
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.
| adverse events | All Subjects |
|---|---|
| Safety / Adverse Events | 0 |
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.
| percentage of agreement | Performance Test |
|---|---|
| Region | 94 |
| Feature | 93 |
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.
| percentage of agreement | Performance Test (Secondary Features) |
|---|---|
| Evaluation of Secondary Histopathology Characteristics | 98 |
Collected over 7+/-3 days after enrollment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VIO Imaging | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
Subjects that are planning to undergo a routine skin biopsy
| Age, Continuous(years) | VIO Imaging |
|---|---|
| Mean | 66 ± 16 |
| Sex: Female, Male(Participants) | VIO Imaging |
|---|---|
| Female | 27 |
| Male | 38 |
| Ethnicity (NIH/OMB)(Participants) | VIO Imaging |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 56 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | VIO Imaging |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 64 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | VIO Imaging |
|---|---|
| United States | 65 |
| Fitzpatrick Skin Type(Participants) | VIO Imaging |
|---|---|
| Type I | 6 |
| Type II | 18 |
| Type III | 27 |
| Type IV | 11 |
| Type V | 3 |
| Type VI | 0 |
| Anatomical Location(Participants) | VIO Imaging |
|---|---|
| Head and Neck | 38 |
| Torso | 6 |
| Limbs | 21 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Enspectra Health