An interventional study of SECM Skin Imaging in Pigmented Lesions, Pigmented Skin Lesion and Pigmented Moles, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-29.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Device feasibility
The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.
SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly.
When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.
19 studies on the registry are indexed under Nevus, Pigmented; 6 are open to participants now.
Browse Nevus, Pigmented studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The 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.
Device: SECM Skin Imaging
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
Number of Participants With Quality Skin Images Obtained From SECM Device
Time frame: Approximate 30 minute study
| Milestone | SECM Skin Imaging |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
| Participants | SECM Skin Imaging |
|---|---|
| Number of Participants With Quality Skin Images Obtained From SECM Device | 15 |
Collected over Imaging data is collected during the procedure (up to 30 minutes).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SECM Skin Imaging | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Event | SECM Skin Imaging |
|---|---|
| Mild, self resolving skin discomfort prior to imagingSkin and subcutaneous tissue disorders | 1/16 |
| Age, Categorical(Participants) | SECM Skin Imaging |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 2 |
| Age, Continuous(years) | SECM Skin Imaging |
|---|---|
| Mean | 36.875 (23 to 70) |
| Sex: Female, Male(Participants) | SECM Skin Imaging |
|---|---|
| Female | 10 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | SECM Skin Imaging |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | SECM Skin Imaging |
|---|---|
| United States | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2021 to primary completion in Oct 2021, 3 months.
Results were first posted in Oct 2025, 4 years after primary completion.
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