Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Optimization Study

Study Overview
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Brief Summary
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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.

Detailed Description
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Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles. Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure, compared baseline. Evaluate skin effects and adverse event rate.

Official Title
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Prospective, Open-Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™) Technology in Healthy Adults With Seborrheic Keratosis

Conditions
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Lesion Skin, Seborrheic Keratosis, Skin Lesion, Benign Skin Tumor

Intervention / Treatment
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* Device: Nano-Pulse Stimulation (NPS)


Participation Criteria
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Eligibility Criteria
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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 by the sponsor, clinic site, or entity associated with the conduct of the study Family member of someone employed by the sponsor, clinic site, or entity associated with the conduct of the study Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study Prior inability to complete required study visits during treatment period. Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nano-Pulse Stimulation (NPS) Treated Lesion<br>Nano-Pulse Stimulation of targeted lesion. | Device: Nano-Pulse Stimulation (NPS)<br>* Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance Rate of SK Lesions | Degree of Clearance of SK lesion treated with NPS as rated by investigators. | 90 days post-last treatment |