Melanoma, SkinNCT06666790
DermaSensor Postmarket Surveillance Study
A study testing Scan with elastic scattering spectroscopy device to assess risk of malignancy in people with Melanoma, Skin, run by DermaSensor, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Melanoma, Skin
- What is being tested?
- Scan with elastic scattering spectroscopy device to assess risk of malignancy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2024to 10 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women of any ethnic group aged 40 and older
- Primary skin lesion suspicious for melanoma
- Patient is willing and able to read, understand, and sign the informed consent form (ICF)
Who cannot join
- Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)
- Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.
- Lesion is greater than 15mm in diameter at the widest point.
- 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.
- Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
- 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).
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- Lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.)
- 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).
- Lesion is located on acral skin (e.g., sole or palms).
- Lesion is located within 10mm of the eye.
- Lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention.
- Lesion is located on mucosal surfaces (e.g. genitals, lips).
- Lesion is located in an area with acute sunburn.
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
West Clinical Research
Morehead City, North Carolina, 28557
Luke Snedaker, 252-515-0050, Info@westclinicalresearch.com
Patrick Morgante
- Recruiting
Velocity
New Smyrna Beach, Florida, 32168
Anna Kipp
Chang
About this study
The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.
- Conditions
- Melanoma, Skin
- Being tested
- Scan with elastic scattering spectroscopy device to assess risk of malignancy
- Keywords
- medical device, skin cancer detection, elastic scattering spectroscopy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scan with elastic scattering spectroscopy device to assess risk of malignancyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Clinical assessment only | No intervention | Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy without ESS device output |
| Clinical assessment with device output | Experimental | Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy with ESS device output Receives: Device: Scan with elastic scattering spectroscopy device to assess risk of malignancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Sensitivity
Measured: 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start8 Oct 2024
- Primary completion11 Apr 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma, SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermaSensor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Slatko, MD, MBA, Study chair, DermaSensor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666790
- Sponsor's protocol ID
- CSP-24-0002
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DermaSensor Postmarket Surveillance Study
- ClinicalTrials.gov ID
- NCT06666790
- Acronym / sponsor ID
- CSP-24-0002
- Conditions
- Melanoma, Skin
- Keywords
- medical device, skin cancer detection, elastic scattering spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- DermaSensor, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 11 Apr 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinical assessment only | No intervention | –Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy without ESS device output |
| Clinical assessment with device output | Experimental | Device: Scan with elastic scattering spectroscopy device to assess risk of malignancyLesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy with ESS device output |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women of any ethnic group aged 40 and older
- Primary skin lesion suspicious for melanoma
- Patient is willing and able to read, understand, and sign the informed consent form (ICF)
Key exclusion criteria (14 listed)
- Lesion is not accessible to the DermaSensor device Handheld Unit and tip (e.g., inside ears, under nails, etc.)
- Lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate DermaSensor device tip placement on the lesion.
- Lesion is greater than 15mm in diameter at the widest point.
- 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.
- Lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scan with elastic scattering spectroscopy device to assess risk of malignancyElastic 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 | Device | Clinical assessment with device output |
Primary outcome
Device Sensitivity
Time frame: 39 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary Slatko, MD, MBA study chair
DermaSensor, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scan with elastic scattering spectroscopy device to assess risk of malignancy in people with Melanoma, Skin, run by DermaSensor, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Frazier, MS (508-776-0044, justin.frazier@dermasensor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Sensitivity (time frame: 39 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.