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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-06

Study Completion Date

2022-02-08

Brief Summary

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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 tomography (FF-OCT) device - the ApolloVue® S100 Image System in imaging skin microstructures of healthy skin at different anatomical locations and nevi for different skin types and different age and to evaluate usability of the ApolloVue® S100 Image System.

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Detailed Description

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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 high tissue penetration depth that are highly valuable for clinical use. This technology allows visualization of important structural features such as the epidermis and dermis and the epidermal-dermal junction. OCT has the advantage of generating cross-sectional images, like the orientation of pathology slides.

The ApolloVue® S100 Image System is intended to be used as a non-invasive imaging tool in the evaluation of external human skin tissue microstructure by providing two-dimensional, crosssectional (B-scan) and en face (E-scan) real-time visualization for assessment by physicians to support in forming a clinical judgment. For the ApolloVue® S100 Image System image, both cross-sectional view and en face view can be obtained to assist physicians' diagnosis. With both views, physicians can obtain important spatial information in regards to the skin. Besides, the ApolloVue® S100 Image System is equipped with an image guiding system which provides a high-resolution dermatoscope like image, for the positioning of skin sites for optical biopsies.

In this protocol, it is proposed to study the optical imaging features of healthy human skin and nevi and the evaluation of usability. We propose to recruit 60 subjects for such a trial. Healthy volunteers will be approached and consented to this protocol. The volunteers will be imaged.

Conditions

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Healthy Skin Nevus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Heathy volunteers

Patients has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, calf and at least a nevus without superficial scales and crusting.

ApolloVue® S100 Image System

Intervention Type DEVICE

The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 3 quality OCT images of B-scan (cross-section) and E-scan (en face) with 4 depths for each skin site respectively for each skin site. There is a total of 6 skin sites.

Interventions

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ApolloVue® S100 Image System

The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 3 quality OCT images of B-scan (cross-section) and E-scan (en face) with 4 depths for each skin site respectively for each skin site. There is a total of 6 skin sites.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. All age will be recruited.
2. Both genders will be recruited.
3. 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)
4. Has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, and calf.
5. Has at least a nevus without superficial scales and crusting
6. Willing to provide informed consent

4. Not willing to cooperate with methods and related procedures of this trial/study