Nano-Pulse Stimulation (NPS) in Sebaceous Hyperplasia 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 Sebaceous Hyperplasia (SH) lesions from facial areas of healthy adult subjects.

Detailed Description
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Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles. Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points. 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 Sebaceous Hyperplasia

Conditions
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Sebaceous Hyperplasia, Skin Abnormalities, Skin Lesion

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 18 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 are willing to return for all the required follow-up visits. Understands that SHs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit Must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of SH lesion and at 30- and 60-days post-retreatment. Clinically diagnosis of typical sebaceous hyperplasia. Minimum of four SH lesions. Undergo all study procedures including consent for photographs of the treated SH sites. Agrees to refrain from using all other SH lesion removal products or treatments (topical medication including over-the-counter medications) during the study period. Exclusion Criteria: Implantable electronic devices (i.e., pacemaker, implantable cardioverter 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 a 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. 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. Known 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 target lesion. | Device: Nano-Pulse Stimulation (NPS)<br>* Electrical pulses (nanosecond duration) applied directly to target SH 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 |
| --- | --- | --- |
| SH Lesion Clearance Rate | Clearance of SH lesions treated with NPS as rated by investigators. | 60-days post-last NPS treatment |