CellFX Treat & Resect BCC Feasibility Study

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    30
  • sponsor
    Pulse Biosciences, Inc.
Updated on 17 June 2021

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 for complete histological clearance of the target lesion followed by surgical tumor excision 60 days post-treatment.

Description

The study will enroll healthy adult subjects with confirmed low-risk 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.

Details
Condition Basal cell carcinoma, Excision Margin, basal cell carcinomas, basal cell carcinoma of skin
Treatment CellFX System
Clinical Study IdentifierNCT04918381
SponsorPulse Biosciences, Inc.
Last Modified on17 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is at least 22 and no older than 85 years of age
Subject has 1-2 primary, non-recurrent, superficial, or nodular visible basal cell carcinoma lesion up to 1.5 cm in size with well-defined borders that has been verified by biopsy
Lesion(s) is appropriate for full linear excision with 5 mm margins
Subject is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
Subject is willing to have BCC lesion(s) treated in a single treatment session and must comply with all study procedures including follow-up visits
Subject consents to have photographs taken of the BCC lesion(s)
Subject agrees to refrain from using all other lesion removal products or treatments (topical medication including over-the-counter medications or treatments from PI or another physician) during the study period
Subject agrees to refrain from prolonged sun exposure of the treatment area during the study period

Exclusion Criteria

Subject has an implantable electronic medical device (i.e., pacemaker, implantable cardioverter defibrillator)
Subject has an active infection or history of infection in designated test area within four weeks prior to treatment
Subject is not willing or able to sign the Informed Consent
Subject is known to be immune compromised/has a history of immunosuppression (e.g., organ transplant, long-term use of psoralen) or genetic disease (e.g., nevoid basal cell carcinoma syndrome [Gorlin syndrome], xeroderma pigmentosum)
The basal cell carcinoma lesion intended for treatment with the CellFX System is on the face, neck, scalp, axilla, hands, feet, or genitals
The basal cell carcinoma intended for treatment with the CellFX System is a high-risk BCC subtype including perineurial, infiltrative, sclerosing, morpheaform, desmoplastic, micronodular, basosquamous or exhibiting aggressive growth patterns
Subject is known to be a keloid producer
Subject has allergies to Lidocaine or Lidocaine-like products
Subject has a history of radiation to the area intended for treatment
Subject has current or prior metastatic BCC
Subject is currently being treated or has been previously treated with Sonidegib or Vismodegib
Subject has recurrent BCC lesions
Subject has a systemic infection
Subject has a history of epilepsy
Subject has a history of cardiac arrhythmia, myocardial infarction or structural heart disease
Subject is employed by the sponsor, clinic site, or entity associated with the conduct of the study
Subject has any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
Subject has a history of use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study, with the exception of participation in a COVID vaccination related clinical trial
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