MedTrace Logo

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

NCT04406454 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-11-14

No results posted yet for this study

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 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.

Conditions

  • Healthy Skin
  • Nevus

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Apollo Medical Optics, Ltd

    collaborator INDUSTRY

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Ding-Dar Lee, M.D., Ph. D · Taipei Veterans General Hospital, Taiwan

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2021-09-01
Completion
2022-02-08

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406454 on ClinicalTrials.gov