Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566302
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-07-27
First Post:
2020-08-11
Brief Title:
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None