Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography
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|ClinicalTrials.gov Identifier: NCT04935424|
Recruitment Status : Recruiting
First Posted : June 23, 2021
Last Update Posted : August 10, 2021
OCT is an optical technology that emerged as a non-invasive skin imaging for the skin. In this protocol, the investigators plan to study the optical imaging features of leukoderma. An estimated 50 subjects will be included in this trial.
This is an observational, non-randomised, non-controlled, prospective cohort study to observe the feasibility of in vivo OCT as a image tool in the diagnosis of leukoderma. Use of the device will not affect the clinical management of the subjects.
To evaluate the feasibility ApolloVue S100 image system as a tool in the differential diagnosis of leukoderma..
|Condition or disease||Intervention/treatment|
|Leukoderma||Device: ApolloVue® S100 Image System (Apollo Medical Optics)|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Evaluation of Treatment for Leukoderma by Cellular Level Resolution Full-field Optical Coherence Tomography|
|Actual Study Start Date :||August 3, 2021|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2022|
Device: ApolloVue® S100 image system
Device: ApolloVue® S100 Image System (Apollo Medical Optics)
The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 6 medical images of normal and lesional skin, respectively, for both experimental group and control group. The ApolloVue S100 image system is a high resolution OCT imaging system that provide real-time visualization of human skin tissue microstructure. The system provides cellular level, two-dimensional, cross-sectional (B-scan) and en face (E-scan) that can assist clinical diagnosis.The system is also equipped with imaging guiding system that could assist in position scanning skin area.
Other Name: 510(K) Number: K201552 (class II)
- To describe characteristic features seen by Full-field Optical Coherence Tomography of leukoderma disorders. [ Time Frame: 6 months ]The study is a descriptive one. To researche the characteristic images of leukoderma. No formal statistical testing of correlations will be performed. All images will be evaluated as a group. First, the investigator will review the OCT images for each imaging site and will determine the presence/absence of leukoderma. Next, comparing with the leukoderma disorders images to highlight any features that may assist in the OCT evaluation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04935424
|Contact: Chau Yee Ng, MD||+886-3-3281200 ext firstname.lastname@example.org|
|Linkou Chang Gung Memorial Hospital||Recruiting|
|Taoyuan City, Taiwan, 33305|
|Contact: Chau Yee Ng, MD +886-3-3281200 ext 3556 email@example.com|