BCC - Basal Cell CarcinomaNCT04918381
CellFX Treat & Resect Low-Risk BCC Feasibility Study
A study testing CellFX System in people with BCC - Basal Cell Carcinoma and BCC, run by Pulse Biosciences, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- BCC - Basal Cell Carcinoma, BCC, Excision Margin
- What is being tested?
- CellFX System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Jun 2021to 22 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Moy-Fincher-Chipps Dermatology
Beverly Hills, California, 90210
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Palm Harbor Dermatology
Clearwater, Florida, 34685
Surgical Dermatology Group
Vestavia Hills, Alabama, 35242
About this 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
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.
Read the 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.
- Conditions
- BCC - Basal Cell Carcinoma, BCC, Excision Margin
- Being tested
- CellFX System
- Keywords
- CellFX, Nano-Pulse Stimulation, NPS, Clearance
- Medical subject headings
- Carcinoma, Basal Cell, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellFX SystemDevice
Nano-Pulse Stimulation (NPS)
| Study group | Role | What they receive |
|---|---|---|
| CellFX Procedure | Experimental | Treatment of the BCC with CellFX System Receives: Device: CellFX System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60-days post-CellFX procedure
Number of Participants With Treatment Related Serious Adverse Events
No serious adverse events related to CellFX Treatment or Procedure
Measured: 60-days post-CellFX procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start2 Jun 2021
- Primary completion2 Mar 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BCC - Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- CellFX System
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A. Nuccitelli, PhD, Study chair, Pulse Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918381
- Sponsor's protocol ID
- NP-TR-014
- Status last verified
- Dec 2022
- First submitted
- 30 May 2021
- Last updated
- 11 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04918381
- Acronym / sponsor ID
- NP-TR-014
- Conditions
- BCC - Basal Cell Carcinoma, BCC, Excision Margin
- Keywords
- CellFX, Nano-Pulse Stimulation, NPS, Clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Posted 14 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- CellFX System
| Arm | Type | Receives |
|---|---|---|
| CellFX Procedure | Experimental | Device: CellFX SystemTreatment of the BCC with CellFX System |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellFX SystemNano-Pulse Stimulation (NPS) | Device | CellFX Procedure |
Primary outcome
Number of Lesions With BCC Histological Clearance
Time frame: 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
Time frame: 60-days post-CellFX procedure
No serious adverse events related to CellFX Treatment or Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A. Nuccitelli, PhD study chair
Pulse Biosciences, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX System in people with BCC - Basal Cell Carcinoma and BCC, run by Pulse Biosciences, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lesions With BCC Histological Clearance (time frame: 60-days post-CellFX procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.