| Eligibility |
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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