NCT05068310 Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
| NCT ID | NCT05068310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Apollo Medical Optics, Ltd |
| Condition | Skin Lesion |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-10-21 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-10-21 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The incidence of skin cancer has been continuously increasing over the past decades und the number of non melanoma skin cancer is well as melanoma is still going to increase. Invasive biopsy and histological examination represents the gold standard in diagnosis of benign and malignant skin tumors. However, novel technologies such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) have been introduced in dermatology. Multiple studies have shown the applicability of both technologies for diagnosis of skin tumors as well as other skin diseases and to increase the specificity of diagnosis resulting in the reduction of unnecessary biopsies. New technological developments resulted in a high resolution OCT scanner (AMO, Taiwan), which allows vertical and horizontal evaluation (3D) of the skin at cellular resolution and up to a depth of around 400 μm and thus combines the advantages of both above mentioned techniques. ApolloVue® S100 Image System is a FDA-cleared 510(k) Class II medical device. Other non-invasive imaging method (reflectance confocal microscopy and conventional optical coherence tomography) will be used to evaluate a subset of skin lesions.
Eligibility Criteria
Inclusion Criteria: * Patients aged \> 18 years * Willingness to participate in this study including the assessment with high resolution OCT * Skin lesion/tumor with suspicion for skin cancer that requires skin biopsy or complete excision * Benign skin tumor that is scheduled for excision due to suspicion, irritation or for cosmetic reason Exclusion Criteria: * Patients aged \< 18 years * Any unstable medical or psychological conditions * Unwillingness to participate in this study including the assessment with high resolution OCT
Frequently Asked Questions
Who can join the NCT05068310 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Skin Lesion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05068310 currently recruiting?
Yes, NCT05068310 is actively recruiting participants. Visit ClinicalTrials.gov or contact Apollo Medical Optics, Ltd to inquire about joining.
Where is the NCT05068310 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT05068310 clinical trial?
NCT05068310 is sponsored by Apollo Medical Optics, Ltd. The trial plans to enroll 200 participants.