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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Nano-Pulse Stimulation (NPS)
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
Number of Lesions With BCC Histological Clearance
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.
Time frame: 60-days post-CellFX procedure
Number of Participants With Treatment Related Serious Adverse Events
No serious adverse events related to CellFX Treatment or Procedure
Time frame: 60-days post-CellFX procedure
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Clinical Research Center of the Carolinas
Charleston, South Carolina, United States