Status:
COMPLETED
The Application of Non-invasive and Cellular Level Resolution Fullfield Optical Coherence Tomography: Establishment and Analysis of Subcutaneous Cellular Level Image Database of Anatomical Locations in Healthy Volunteers and Evaluation of Usability
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
Apollo Medical Optics, Ltd
Conditions:
Healthy Skin
Nevus
Eligibility:
All Genders
Brief Summary
ApolloVue® S100 Image System is a medical device class II. The objective of this protocol is to image skin of healthy volunteers and to evaluate the performance of full-field optical coherence tomogra...
Detailed Description
The OCT can provide cellular resolution (\~1μm in lateral and axial directions) images. A cellular resolution OCT has the characteristics of non-invasive, non-radioactive, labelfree, real-time and hig...
Eligibility Criteria
Inclusion
- All age will be recruited.
- Both genders will be recruited.
- All skin types will be recruited. Skin type I-VI (Fitzpatrick scale)
- Type I always burns, never tans (unexposed skin color: white)
- Type II usually burns, tans less than average (with difficulty) (unexposed skin color: white)
- Type III sometimes mild burns, tans about average (unexposed skin color: white)
- Type IV rarely burns, tans more than average (with easy) (unexposed skin color: white)
- Type V very rarely burns (unexposed skin color: brown)
- Type VI never burns (unexposed skin color: black)
- Has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, and calf.
- Has at least a nevus without superficial scales and crusting
- Willing to provide informed consent
Exclusion
- Individuals who have a systemic skin disorder.
- Individuals who have a history of severe skin condition
- Individuals with surgeries/cosmetic surgeries/micro cosmetic surgery (eg. cosmetic injections and/or laser etc.) on healthy skin at the 5 anatomical locations and nevi (see inclusion criteria 5) in last 12 months and a physician determine the surgery will affect outcome of the OCT images.
- Not willing to cooperate with methods and related procedures of this trial/study
Key Trial Info
Start Date :
July 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04406454
Start Date
July 6 2020
End Date
February 8 2022
Last Update
November 14 2023
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan, 11217