NCT04918381

CellFX Treat & Resect Low-Risk BCC Feasibility Study

Completed NA Results posted Last updated 11 January 2023

What this trial tests

NA trial testing CellFX System in BCC - Basal Cell Carcinoma in 30 participants. Completed in 22 July 2022.

Timeline

2 June 2021

Primary endpoint
2 March 2022

22 July 2022

Quick facts

Lead sponsor	Pulse Biosciences, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	2 June 2021
Primary completion	2 March 2022
Estimated completion	22 July 2022
Sites	5 locations across United States

Drugs / interventions tested

• CellFX System

Conditions studied

• BCC - Basal Cell Carcinoma — all drugs for BCC - Basal Cell Carcinoma →
• BCC — all drugs for BCC →
• Excision Margin — all drugs for Excision Margin →

Sponsor

Pulse Biosciences, Inc.

Who can join

Adults 22 to 85, any sex, with BCC - Basal Cell Carcinoma or BCC. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Lesions With BCC Histological Clearance Primary · 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.

Group	Value	95% CI
CellFX Procedure	34

Number of Participants With Treatment Related Serious Adverse Events Primary · 60-days post-CellFX procedure

No serious adverse events related to CellFX Treatment or Procedure

Group	Value	95% CI
CellFX Procedure	0

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events were collected during the course of study at Visit days at 0 days, 3 days, 7 days, 14 days, 30 days, and 60 days after CellFX Treatment and at 14 days, 30 days, and 60 days post-surgical excision (total time period of 120 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

CellFX Procedure

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (2 terms — click to expand)

Reaction	System	CellFX Procedure
Folliculitis	Infections and infestations	—
Infection	Infections and infestations	—

Data from ClinicalTrials.gov NCT04918381 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances of medical nanorobots for future cancer treatments.
   Kong X, Gao P, Wang J, Fang Y, et al · · 2023 · cited 74× · PMID 37452423 · DOI 10.1186/s13045-023-01463-z
2. Multicenter, prospective feasibility study of Nano-Pulse Stimulation™ technology for the treatment of both nodular and superficial low-risk basal cell carcinoma.
   Ross AS, Schlesinger T, Harmon CB, Moy RL, et al · · 2022 · cited 5× · PMID 36531070 · DOI 10.3389/fonc.2022.1044694