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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05619471
Other study ID # CR-30096
Secondary ID 2R44CA221591-03
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2022
Est. completion date August 11, 2023

Study information

Verified date April 2024
Source Enspectra Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date August 11, 2023
Est. primary completion date August 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: 1. The subject is between 18 and 99 years of age. 2. The subject or Legally Authorized Representative (LAR) is able and willing to provide written informed consent. 3. The subject is planning to undergo a routine skin biopsy. 4. The subject is willing and able to remain still for periods of up to 3 minutes to allow for image capture. 5. The subject or LAR has sufficient mental capacity to understand the informed consent form (ICF) and comply with the protocol requirements. Exclusion Criteria: 1. The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation. 2. The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin. 3. The subject's lesion targeted for biopsy: 1. Is located on the palms of the hands, soles of the feet, fingernails, or toenails. 2. Has dense hair that will not be removed prior to the skin biopsy. 3. Has clinically significant abraded or ulcerated skin with or without discharge. 4. Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation 5. Is located in mucosal tissue (i.e., oral, nasal, etc.). 6. Is on tattooed skin. 7. Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.) 8. Is located in the periorbital region or directly on the eyelid. -

Study Design


Intervention

Device:
VIO Imaging
Skin conditions that are candidates for skin biopsies

Locations

Country Name City State
United States Golden State Dermatology Merced California
United States Golden State Dermatology Walnut Creek California

Sponsors (3)

Lead Sponsor Collaborator
Enspectra Health National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ward WH, Farma JM, editors. Cutaneous Melanoma: Etiology and Therapy [Internet]. Brisbane (AU): Codon Publications; 2017 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK481860/ — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Effectiveness 1. 100% agreement and validation of specific tissue features on VIO images (epidermis, dermis, collagen, blood vessels and pigment) in comparison to gold standard pathology images in Comparative Reader assessment. 3-months post-Enrollment completion
Primary Safety and Effectiveness 2. >90% agreement between Blinded Reader VIO image assessment and answer key developed from validation assessment. 3-months post-Enrollment completion
Primary Safety and Effectiveness 3. 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. 7day +/- 3 days
Secondary 1) 90% inter-reader agreement during image analysis phase of the study on the images captured using the investigational device 1) 90% inter-reader agreement during image analysis 3 months post enrollment completion
Secondary 2) Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captures on investigational device VIO Evaluation of secondary histopathology characteristics using a questionnaire to identify skin features on the images captured on the investigational device VIO; including but not limited to
Dermal elastosis
Cellular nodules within dermis will be evaluated during image analysis
Large keratinocytes
3 months post enrollment completion
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