AI mole checker tested at home – but trial stops early
NCT ID NCT05321784
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a device called the Sklip System, which uses artificial intelligence, could help people at home decide if a mole might be skin cancer. Only one person took part before the study was stopped early. The goal was to see if the AI could match or beat standard methods for spotting cancers like melanoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sklip System (AI-powered dermoscopy device)
- What this could lead to
- If successful, this could allow people to safely check their own moles at home for skin cancer, reducing unnecessary doctor visits.
- What could go wrong
- The trial was terminated early with only 1 participant, so no reliable conclusions can be drawn. The technology may not be accurate enough for home use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1 person
The number who actually took part.
- Started
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Sep 2023
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participant or legally authorized representative (LAR) must provide written informed consent before any Study-specific procedures or interventions are performed. 2. 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. 3. Participant self-identifies as having Fitzpatrick Skin Type 1 through 4. 4. Participant must be a current or new patient through self-referral or Provider-referral at the participating Study Site. 5. 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) 6. 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. 7. 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 Criteria: 1. Participant who self-identifies having Fitzpatrick Skin Type 5 or 6. 2. 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. 3. Vulnerable populations including children, prisoners, and decisional impaired adults as well as vision impaired adults will not be eligible for this Study. 4. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
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