Spots Global Cancer Trial Database for CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

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Trial Identification

Brief Title: CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

Official Title: A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Cryosurgery for the Treatment of Cutaneous Non-Genital Common Warts

Study ID: NCT04738734

Conditions

Warts

Warts Hand

Verruca

Interventions

CellFX System Device

Cryosurgery Liquid Nitrogen Sprayer

Study Description

Brief Summary: This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.

Detailed Description: The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. Macrophotography of all study warts will be captured along with a blinded site Investigator to characterize wart healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and 90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible for up to a total of 3 treatments over the course of the study. Adverse events will be documented.