BCC, BCC - Basal Cell Carcinoma, Excision Margin
Conditions
Keywords
CellFX, Nano-Pulse Stimulation, NPS, Clearance
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.
Interventions
DEVICECellFX System
Nano-Pulse Stimulation (NPS)
Sponsors
Pulse Biosciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
CellFX System
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With BCC Histological Clearance | 60-days post-CellFX procedure | 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. |
| Number of Participants With Treatment Related Serious Adverse Events | 60-days post-CellFX procedure | No serious adverse events related to CellFX Treatment or Procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CellFX Procedure Treatment of the BCC with CellFX System
CellFX System: Nano-Pulse Stimulation (NPS) | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | CellFX Procedure |
|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Histological presence of superficial or nodular BCC | 37 lesions |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CellFX Procedure | Number of Lesions With BCC Histological Clearance | 34 BCC Lesions |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CellFX Procedure | Number of Participants With Treatment Related Serious Adverse Events | 0 Participants |