CellFX Treat & Resect Low-Risk BCC Feasibility Study
NCT04918381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-01-11
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.
Conditions
- BCC - Basal Cell Carcinoma
- BCC
- Excision Margin
Interventions
- DEVICE
-
CellFX System
Nano-Pulse Stimulation (NPS)
Sponsors & Collaborators
-
Pulse Biosciences, Inc.
lead INDUSTRY
Principal Investigators
-
Richard A. Nuccitelli, PhD · Pulse Biosciences, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-06-02
- Primary Completion
- 2022-03-02
- Completion
- 2022-07-22
- FDA Device
- Yes
Countries
- United States
Study Locations
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