NCT05133427

HIFU for Treatment of Non-nodular and Recurrent BCC

High-Intensity Focused Ultrasound (HIFU) for Treatment of Non-nodular and Recurrent Basal Cell Carcinomas of the Skin: Efficacy and Safety.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Joergen Serup · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to demonstrate the safety and efficacy of removal of Basal Cell Carcinoma (BCC) using a new investigational equipment based on high-intensity focused ultrasound. Basal cell carcinoma is the most common cancer in Europe, Australia and the U.S.A. The general upwards age shift in the population in these regions is expected to be accompanied by an increase in the incidence of this type of cancer. There are currently more the 20.000 BCC registrations in Denmark every year, and occurrences on a global scale are counted in several tens of millions per year. Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective. The investigational device used in the investigation is a Danish developed 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 3-5 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

• Carcinoma, Basal Cell

Interventions

Type	Name	Description
DEVICE	TOOsonix system ONE-M	All selected BCC areas will be treated by high intensity focused ultrasound

Timeline

• Start date: 2022-03-21
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2021-11-24
• Last updated: 2025-10-03

Locations

2 sites across 1 country: Denmark