Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study (NCT03846531) | Clinical Trial Compass
CompletedNot Applicable
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
United States58 participantsStarted 2017-05-04
Plain-language summary
The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing to sign the informed consent
* Has a clinical diagnosis of stable, clinically typical seborrheic keratosis
* Medically determined candidate for at least 4 off-face SK lesions
* Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm
* Willing to have three of the designated SK lesions treated in a single treatment session
* Willing to return to the PI's office for five additional study visits at specified intervals over 106-days
* Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion
* No subject identity will be possible via the "lesion-only" photograph
* No evidence of active infection in the designated tissue prior to treatment
* Is not allergic to Lidocaine or Lidocaine-like products
* Not pregnant or lactating
Exclusion Criteria:
* Has an implantable electronic device (e.g., automatic defibrillator)
* Active infection or history of infection within 90 previous days in designated test area
* Not willing or able to sign the Informed Consent
* Non-English speaking or reading
* Is known to be immune-compromised
* Known to be a keloid producer
* On blood thinning medications
* Diseases, conditions, or situations wherein the P…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.