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Brief Title: CellFX Treat & Resect Low-Risk BCC Feasibility Study
Official Title: A Multicenter, Prospective, Treat and Resect Feasibility Study of the CellFX System for the Treatment of Low-Risk Basal Cell Carcinoma (BCC) Lesions
Study ID: NCT04918381
Brief 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.
Minimum Age: 22 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Surgical Dermatology Group, Vestavia Hills, Alabama, United States
Moy-Fincher-Chipps Dermatology, Beverly Hills, California, United States
Palm Harbor Dermatology, Clearwater, Florida, United States
SkinCare Physicians, Chestnut Hill, Massachusetts, United States
Clinical Research Center of the Carolinas, Charleston, South Carolina, United States
Name: Richard A. Nuccitelli, PhD
Affiliation: Pulse Biosciences, Inc.
Role: STUDY_CHAIR