CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
CellFX System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04539886
NCT04539886N/ACompleted
CompareCT.gov

A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Electrodessication (Hyfrecator Electrosurgical) for the Treatment of Sebaceous Hyperplasia (SH) Lesions

Pulse Biosciences, Inc.·interventional·Posted Sep 7, 2020·Updated Apr 25, 2024

In Brief

A clinical study evaluating CellFX System and Intralesional Electrodesiccation for Skin Lesion and 2 related conditions. Completed, enrolled 60 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Lesion, Skin Abnormalities, Sebaceous Hyperplasia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 7, 2020
Enrollment StartSep 28, 2020
Primary CompletionFeb 2, 2021
Study CompletionNov 18, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.8 years ago

Interventions

CellFX Systemdevice

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)

Intralesional Electrodesiccationdevice

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