Neoplasms

All Conditions

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

CellFX System

Richard A. Nuccitelli, PhD

This prospective, multicenter, study is designed to evaluate the safety and effectiveness of the CellFX System in adults subjects with low-risk basal cell carcinoma (superficial and nodular) for complete histological clearance of the target lesion followed by surgical tumor excision 60 days post-treatment.

The study will enroll healthy adult subjects with confirmed low-risk (superficial and nodular) BCC lesion(s) by biopsy, excluding BCCs located on the face, neck, scalp, axilla, hands, feet, and genitals not exceeding 1.5 cm. Macrophotography of all study BCCs will be captured and clinically assessed by the site investigator for characterization of healing and scar appearance prior to and post-surgical excision. All subjects will be followed at 3, 7, 14, 30 and 60-days post-CellFX procedure and at 14, 30 and 60-days post-excision. Adverse events will be documented.

CellFX Treat & Resect Low-Risk BCC Feasibility Study

A Multicenter, Prospective, Treat and Resect Feasibility Study of the CellFX System for the Treatment of Low-Risk Basal Cell Carcinoma (BCC) Lesions

The primary effectiveness endpoint is the total number of lesions with complete histological clearance of the BCC lesion during histological review of microscopic analysis using H \& E slides. Counts and proportions will be assessed.

No serious adverse events related to CellFX Treatment or Procedure

Pulse Biosciences, Inc.

Treatment of the BCC with CellFX System

CellFX System: Nano-Pulse Stimulation (NPS)

CellFX Procedure

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Histological presence of superficial or nodular BCC

The total number of enrolled subjects in this study was 30 participants with 37 lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CellFX Treat & Resect Low-Risk BCC Feasibility Study	NCT04918381	BCC - Basal Cel... BCC Excision Margin	CellFX System	22 Years - 85 Years	Pulse Biosciences, Inc.
CellFX Treat & Resect Low-Risk BCC Feasibility Study	NCT04918381	BCC - Basal Cel... BCC Excision Margin	CellFX System	22 Years - 85 Years	Pulse Biosciences, Inc.

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