Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2024-04-01
2025-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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OCT Guided C&D Group
Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C\&D.
Optical Coherence Tomography (OCT)
VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.
Curettage & Desiccation (C&D) Procedure
Standard of care C\&D where the basal cell carcinoma lesion will be scraped to its base using a Fox dermal curette and an electrodesiccation machine.
Interventions
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Optical Coherence Tomography (OCT)
VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.
Curettage & Desiccation (C&D) Procedure
Standard of care C\&D where the basal cell carcinoma lesion will be scraped to its base using a Fox dermal curette and an electrodesiccation machine.
Eligibility Criteria
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Inclusion Criteria
* Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery
* No prior treatment on the lesion within the last 3 months.
* Lesions anywhere except the head, neck and distal extremities.
* Willing and able to sign informed consent
Exclusion Criteria
* Recurrent tumors.
* Lesion treated within last 3 months.
* Lesions on head and neck (high risk areas)
* Lesions on distal extremities (thin epidermis not preferred for OCT).
* Pregnant women.
* Patients less than 18 years old.
* Prisoners.
* Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Keyvan Nouri
Professor
Principal Investigators
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Keyvan Nouri, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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Maria V Muniz
Miami, Florida, United States
Countries
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Other Identifiers
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20200212
Identifier Type: -
Identifier Source: org_study_id
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