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Comparative Study Between CellFX and Electrodessication in Sebaceous Hyperplasia (SH) Lesions

NCT04539886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-25

Study results available
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Summary

This study is designed as a multi-center, single-blinded, prospective, randomized, study to compare the safety and effectiveness of the CellFX System to the comparator group, Electrodessication for the treatment of SH lesions in healthy adult subjects.

Conditions

  • Skin Lesion
  • Skin Abnormalities
  • Sebaceous Hyperplasia

Interventions

DEVICE

CellFX System

CellFX System consists of a console combined with a handpiece and coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm)

DEVICE

Intralesional Electrodesiccation

Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode

Sponsors & Collaborators

  • Pulse Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Nuccitelli, PhD · Pulse Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2021-02-02
Completion
2021-11-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539886 on ClinicalTrials.gov