Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
1 other identifier
interventional
16
1 country
1
Brief Summary
The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedStudy Start
First participant enrolled
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2021
CompletedResults Posted
Study results publicly available
October 29, 2025
CompletedOctober 29, 2025
October 1, 2025
3 months
August 11, 2020
May 2, 2025
October 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Quality Skin Images Obtained From SECM Device
Approximate 30 minute study
Study Arms (1)
SECM Skin Imaging
EXPERIMENTALThe SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. First, the skin lesion (such as a mole) will be identified on a forearm of the subject. The lesion will be imaged first with a dermatoscope, and then with the SECM device. A dermatoscope is a hand-held device used for the visual observation of the epidermis. It is a superior surface contact microscope used to examine skin lesions.
Interventions
Consented Participants will be asked to allow their forearm to be imaged by the dermatoscope on the same skin/lesions as a control comparison. We will be trying to image pigmented skin/lesions present on the forearm. This will be followed by imaging using the SECM Skin imaging device
Eligibility Criteria
You may qualify if:
- Healthy adults
- years of age or older
- Capable of giving informed consent
- Pigmented lesions (such as moles) present on the forearm
You may not qualify if:
- Unable to provide consent
- Open cuts/sores on the skin, skin infection, or any contagious skin condition
- Pregnant women (according to subject)
- Employees under the direct supervision of the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Guillermo Tearney, MD, PhD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Tearney, M.D, PhD.
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator - MD, PhD, FACC, FCAP, FNAI
Study Record Dates
First Submitted
August 11, 2020
First Posted
September 28, 2020
Study Start
July 19, 2021
Primary Completion
October 22, 2021
Study Completion
October 22, 2021
Last Updated
October 29, 2025
Results First Posted
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share