Trial Outcomes & Findings for CellFX Treat & Resect Low-Risk BCC Feasibility Study (NCT NCT04918381)

Last Updated: 2023-01-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

60-days post-CellFX procedure

Results posted on

2023-01-11

Participant Flow

Unit of analysis: BCC Lesions

Participant milestones

Participant milestones
Measure	CellFX Procedure Treatment of the BCC with CellFX System CellFX System: Nano-Pulse Stimulation (NPS)
Overall Study STARTED	30 37
Overall Study COMPLETED	30 37
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CellFX Treat & Resect Low-Risk BCC Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CellFX Procedure n=30 Participants Treatment of the BCC with CellFX System CellFX System: Nano-Pulse Stimulation (NPS)
Age, Continuous	64.6 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Histological presence of superficial or nodular BCC	37 lesions n=5 Participants

PRIMARY outcome

Timeframe: 60-days post-CellFX procedure

Outcome measures

Outcome measures
Measure	CellFX Procedure n=37 BCC Lesions Treatment of the BCC with CellFX System CellFX System: Nano-Pulse Stimulation (NPS)
Number of Lesions With BCC Histological Clearance	34 BCC Lesions

PRIMARY outcome

Timeframe: 60-days post-CellFX procedure

No serious adverse events related to CellFX Treatment or Procedure

Outcome measures

Outcome measures
Measure	CellFX Procedure n=30 Participants Treatment of the BCC with CellFX System CellFX System: Nano-Pulse Stimulation (NPS)
Number of Participants With Treatment Related Serious Adverse Events	0 Participants

Adverse Events

CellFX Procedure

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CellFX Procedure n=30 participants at risk Treatment of the BCC with CellFX System CellFX System: Nano-Pulse Stimulation (NPS)
Infections and infestations Folliculitis	3.3% 1/30 • Number of events 1 • 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).
Infections and infestations Infection	3.3% 1/30 • Number of events 1 • 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).

Additional Information

William Knape / VP, Clinical, Regulatory and Quality Affairs

Pulse Biosciences, Inc.

Phone: 919-757-2033

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60