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Trial Title:
DermaSensor Postmarket Surveillance Study
NCT ID:
NCT06666790
Condition:
Melanoma, Skin
Conditions: Official terms:
Melanoma
Conditions: Keywords:
medical device
skin cancer detection
elastic scattering spectroscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Enrolled lesions are assessed without and then with the device result as basis for study
investigator decision to biopsy or monitor a potentially malignant lesion.
Primary purpose:
Screening
Masking:
Single (Investigator)
Masking description:
Investigator unaided (i.e., blinded/masked) assessment followed by aided assessment of
each lesion's malignancy risk.
Intervention:
Intervention type:
Device
Intervention name:
Scan with elastic scattering spectroscopy device to assess risk of malignancy
Description:
Elastic scattering spectroscopy device uses a spectrum of light reflectance to compare
suspicious lesion signature to that of previously scanned lesions with known benign or
malignant pathology
Arm group label:
Clinical assessment with device output
Summary:
The objective of this study is to evaluate the sensitivity of the DermaSensor device and
Investigators when used on skin lesions concerning for melanoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men or women of any ethnic group aged 40 and older
2. Primary skin lesion suspicious for melanoma
3. Patient is willing and able to read, understand, and sign the informed consent form
(ICF)
Exclusion Criteria:
1. Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g.,
inside ears, under nails, etc.)
2. Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin
conditions that may impede appropriate DermaSensor device tip placement on the
lesion.
3. Lesion is greater than 15mm in diameter at the widest point.
4. Lesion has a targeted area less than 2.5mm in diameter where the DermaSensor device
tip cannot be placed entirely within the border of the targeted area of the lesion.
5. Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid
discharge (e.g., blood).
6. Lesion is covered by a crust or scale, and lesion surface cannot be cleared of crust
or scale such that there is a contiguous area of at least 2.5mm of cleared intact
skin that is free of any crust, ulceration, erosion or liquid discharge (e.g.,
blood).
7. Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g.,
tattoo, splinter, etc.)
8. Lesion is not completely cleared of (i.e., free of any remaining residue) dermoscopy
oils, makeup, sunscreen, other topical solutions or powders, markings, and staining
treatments (e.g., iodine).
9. Lesion is located on acral skin (e.g., sole or palms).
10. Lesion is located within 10mm of the eye.
11. Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to
any past surgical intervention.
12. Lesion is located on mucosal surfaces (e.g. genitals, lips).
13. Lesion is located in an area with acute sunburn.
14. Dementia or other neurologic, physical or psychological limitation that would
prevent the patient from signing informed consent and/or completing any required
follow-up visits
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Velocity
Address:
City:
New Smyrna Beach
Zip:
32168
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anna Kipp
Investigator:
Last name:
Chang
Email:
Principal Investigator
Facility:
Name:
West Clinical Research
Address:
City:
Morehead City
Zip:
28557
Country:
United States
Status:
Recruiting
Contact:
Last name:
Luke Snedaker
Phone:
252-515-0050
Email:
Info@westclinicalresearch.com
Investigator:
Last name:
Patrick Morgante
Email:
Principal Investigator
Start date:
October 8, 2024
Completion date:
September 10, 2027
Lead sponsor:
Agency:
DermaSensor, Inc.
Agency class:
Industry
Source:
DermaSensor, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06666790
