Status:
TERMINATED
At-Home Dermoscopy Artificial Intelligence
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Malignant Skin Neoplasm
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This is a new protocol to analyze how the use of the Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy...
Detailed Description
PRIMARY OBJECTIVE: I. The Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified perfor...
Eligibility Criteria
Inclusion
- Participant or legally authorized representative (LAR) must provide written informed consent before any Study-specific procedures or interventions are performed.
- Age ≥ 21 years with at least one pigmented skin lesion (PSL)/mole on their body. All genders and members of all races and ethnic groups will be included.
- Participant self-identifies as having Fitzpatrick Skin Type 1 through 4.
- Participant must be a current or new patient through self-referral or Provider-referral at the participating Study Site.
- Participant must have access to a smartphone/tablet and be willing to set up virtual communication via direct message to a Study Site dermatology provider (i.e. MyChart in EPIC, direct message in ModMed EMA or other electronic medical record (EMR) type)
- Participant must be English-speaking due to FDA Breakthrough Designation of the Sklip System in the English language. Therefore, we are unable to accommodate non-English speaking Participants.
- Participant must be "Healthy", which is defined as someone considered not urgently sick or hospitalized. This will be determined by the Study principle investigator (PI) at each Study Site, a licensed dermatologist, who will be responsible for screening Participants to ensure eligibility criteria is met prior to enrollment.
Exclusion
- Participant who self-identifies having Fitzpatrick Skin Type 5 or 6.
- Participant who have had a skin check visit with a dermatology Provider within the last 90 days will be excluded to avoid self-selection bias, unless the Participant identifies a new unexamined (not previously documented) spot of concern.
- Vulnerable populations including children, prisoners, and decisional impaired adults as well as vision impaired adults will not be eligible for this Study.
- Pregnant individuals will be excluded in this Study. Since this is a minimal pregnancy risk category, no special precautions will be taken to determine that the patient is not pregnant
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05321784
Start Date
September 27 2023
End Date
September 30 2024
Last Update
December 29 2025
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239