Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Apollo Medical Optics, Ltd | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ApolloVue® S100 Image System | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the average scanning success rate of obtaining at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively. |
| 2 years |
| Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%). | The purpose of this evaluation is to validate that the ApolloVue® S100 Image System delivers non-invasive skin image features. Required features will be analyzed for each group, including age, skin type and anatomical location. The features need to meet the following requirement in each 500 x 400 µm2 image for B-scan and in each 500 x 500 μm2 image for E-scan. A. Identification of keratinocyte in ≧ 80% of images (B-scan only) B. Identification of stratum corneum in ≧ 80% of images C. Identification of epidermis in ≧ 80% of images D. Identification of dermis in ≧ 80% of images E. Identification of EDJ in ≧ 80% of images F. Identification of collagen in ≧ 80% of images (B-scan only) G. Identification of melanin in ≧ 80% of images | 2 years |
| Determine time required to obtain at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively. | Time required < 20 minutes for each body site except for nevus. Time required < 40 minutes for a nevus including image guiding. | 2 years |
Not provided
Not provided
Inclusion Criteria:
All age will be recruited.
Both genders will be recruited.
All skin types will be recruited. Skin type I-VI (Fitzpatrick scale)
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 Criteria:
Not provided
Not provided
Not provided
Not provided
The population from healthy volunteers will be selected.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ding-Dar Lee, M.D., Ph. D | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Beitou District | 11217 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3377516 | Background | Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available. | |
| 29263332 | Background | Adabi S, Hosseinzadeh M, Noei S, Conforto S, Daveluy S, Clayton A, Mehregan D, Nasiriavanaki M. Universal in vivo Textural Model for Human Skin based on Optical Coherence Tomograms. Sci Rep. 2017 Dec 20;7(1):17912. doi: 10.1038/s41598-017-17398-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D009506 | Nevus |
| ID | Term |
|---|---|
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided