CellFX Treat & Resect Low-Risk BCC Feasibility Study

NCT04918381 | Completed Results FDA Device

• 1 other identifier: NP-TR-014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

BCC - Basal Cell Carcinoma; BCC; Excision Margin

Keywords

CellFX; Nano-Pulse Stimulation; NPS; Clearance

Outcome Measures

Primary Outcomes (2)

• 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.

  60-days post-CellFX procedure

• Number of Participants With Treatment Related Serious Adverse Events

  No serious adverse events related to CellFX Treatment or Procedure

  60-days post-CellFX procedure

Study Arms (1)

CellFX Procedure

EXPERIMENTAL

Treatment of the BCC with CellFX System

Device: CellFX System

Interventions

CellFX System DEVICE

Nano-Pulse Stimulation (NPS)

CellFX Procedure

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (5)

Surgical Dermatology Group

Vestavia Hills, Alabama, 35242, United States

Location

Moy-Fincher-Chipps Dermatology

Beverly Hills, California, 90210, United States

Location

Palm Harbor Dermatology

Clearwater, Florida, 34685, United States

Location

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Margins of Excision

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: William Knape / VP, Clinical, Regulatory and Quality Affairs
• Organization: Pulse Biosciences, Inc.

bknape@pulsebiosciences.com

919-757-2033

Study Officials

• Richard A. Nuccitelli, PhD

  Pulse Biosciences, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: CellFX System

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 8, 2021
• Study Start: June 2, 2021
• Primary Completion: March 2, 2022
• Study Completion: July 22, 2022
• Last Updated: January 11, 2023
• Results First Posted: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)