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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-05

Study Completion Date

2021-04-22

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.

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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.

Conditions

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Lesion Skin Seborrheic Keratosis Skin Lesion Benign Skin Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nano-Pulse Stimulation (NPS) Treated Lesion

Nano-Pulse Stimulation of targeted lesion.

Group Type EXPERIMENTAL

Nano-Pulse Stimulation (NPS)

Intervention Type DEVICE

Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.

Interventions

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Nano-Pulse Stimulation (NPS)

Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.

Intervention Type DEVICE

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No