Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04918381
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2021-05-30
Brief Title:
CellFX Treat Resect Low-Risk BCC Feasibility Study
Sponsor:
Pulse Biosciences Inc
Organization:
Pulse Biosciences Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lesions by biopsy excluding BCCs located on the face neck scalp axilla hands feet and genitals not exceeding 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None