Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study (NCT04249115) | Clinical Trial Compass
TerminatedNot Applicable
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study
Stopped: Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology.
United States175 participantsStarted 2019-02-05
Plain-language summary
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation (NPS) energy settings for lesion clearance of Seborrheic Keratosis (SKs) from off-facial areas of healthy adults.
Who can participate
Age range
21 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:
* Male or Female between 21 and 75 years of age
* Voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
* Understanding of the clinical investigation, agree to cooperate with the investigational procedures and willing to return for all the required follow-up visits
* Understands that SKs are to be treated in a single treatment session and is aware that they may receive a second treatment
* Must be able to visit clinic site at 7-, 30-, 60-, and 90-days post-primary treatment of SK lesion and at retreatment
* Clinical diagnosis of stable, clinically typical Seborrheic Keratosis
* Minimum of two SK lesions
* SKs must be no greater than 2mm in height and not exceed 10mm x 10mm at their largest point
* Undergo all study procedures including consent for global photographs of the SK study sites
* Agrees to refrain from using all other SK lesion removal products or treatments (topical medication including over-the-counter medications) during the study period
Exclusion Criteria:
* Implantable electronic devices (i.e., automatic defibrillator)
* Active infection or history of infection in designated test area within 90 days prior to first treatment
* Not willing or able to sign the Informed Consent
* Known to be immune-compromised
* Known to be keloid producer
* Taking blood thinning medications
* Insulin dependent, Type I diabetics
* Allergies to Lidocaine or Lidocaine-like products
* Employed b…
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.