NCT04253418TerminatedNot Applicable
Prospective, Open Label, Multi-Center, Non-Significant Risk Study of Nano-Pulse Stimulation™ (NPS™ ) Technology in Healthy Adults With Sebaceous Hyperplasia
Pulse Biosciences, Inc.6 sites in 1 country125 target enrollmentStarted: December 20, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Pulse Biosciences, Inc.
- Enrollment
- 125
- Locations
- 6
- Primary Endpoint
- SH Lesion Clearance Rate
Study Overview
Brief Summary
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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Nano-Pulse Stimulation (NPS) Treated Lesion
Experimental
Nano-Pulse Stimulation of target lesion.
Intervention: Nano-Pulse Stimulation (NPS) (Device)
Outcomes
Primary Outcomes
SH Lesion Clearance Rate
Time Frame: 60-days post-last NPS treatment
Clearance of SH lesions treated with NPS as rated by investigators.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
Loading locations...
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