Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05698706
Status:
RECRUITING
Last Update Posted:
2023-02-02
First Post:
2023-01-16
Brief Title:
High Intensity Focused Ultrasound HIFU Treatment of Basal Cell Carcinoma
Sponsor:
Jacek Calik
Organization:
Old Town Clinic Poland
Study Overview
Official Title:
High Intensity Focused Ultrasound HIFU Treatment of Basal Cell Carcinoma Efficacy and Safety
Status:
RECRUITING
Status Verified Date:
2023-01
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:
HIFU-BCC
Brief Summary:
The overall objective of the study is to evaluate the safety and efficacy of treatment of Basal Cell Carcinoma BCC using a new modality based on high-intensity focused ultrasound HIFU BCC is the most common type of skin cancer in Europe Australia and the US It accounts for more than 75 of all skin cancer cases in those regions There are currently more the 14000 BCC cases registrations in Poland every year and occurrences on a global scale are counted in several millions per year Given the trend of aging population those numbers will only increase with time Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective The investigational device used in the study is a system capable of making controlled and targeted thermo-mechanical treatment of small intradermal volumes containing eg BCC cells but without inflicting damage to the surrounding tissue
The investigation involves an evaluation of the safety and efficacy profile 3 months after a single few-minute treatment Subsequent follow-up of secondary endpoints is done every third month until the end of the study one year after the treatment
The investigation involves an evaluation of the safety and efficacy profile 3 months after a single few-minute treatment Subsequent follow-up of secondary endpoints is done every third month until the end of the study one year after the treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None