NCT04918381

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• BCC - Basal Cell Carcinoma
• BCC
• Excision Margin

Interventions

Type	Name	Description
DEVICE	CellFX System	Nano-Pulse Stimulation (NPS)

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-03-02
• Completion: 2022-07-22
• First posted: 2021-06-08
• Last updated: 2023-01-11
• Results posted: 2022-12-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study