Spots Global Cancer Trial Database for CellFX Treat & Resect Low-Risk BCC Feasibility Study

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Trial Identification

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

Conditions

BCC - Basal Cell Carcinoma

BCC

Excision Margin

Interventions

CellFX System

Study Description

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.