NCT05698706

High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma

High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma: Efficacy and Safety

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Jacek Calik · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 e.g. 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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DEVICE	TOOsonix System ONE-M	Selected BCC sites will be treated using high intensity focused ultrasound

Timeline

• Start date: 2022-12-14
• Primary completion: 2025-05-14
• Completion: 2025-05-14
• First posted: 2023-01-26
• Last updated: 2023-02-02

Locations

1 site across 1 country: Poland