HIFU for Treatment of Non-nodular and Recurrent BCC (BCC-HIFU2101)
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|ClinicalTrials.gov Identifier: NCT05133427|
Recruitment Status : Recruiting
First Posted : November 24, 2021
Last Update Posted : March 22, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Basal Cell||Device: TOOsonix system ONE-M||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
The study is a multicenter (two-center), open-label study in humans (hospital outpatients). The study is not comparative with respect to the two study groups; however, it is aimed to pool data if the study groups are statistically comparable.
The investigation is performed prior to CE mark to confirm safety and performance of the System ONE-M device when used as intended, i.e. as an non-invasive method to remove non-nodular basal cell carcinoma by 20 MHz high intensity focused ultrasound.
|Masking:||None (Open Label)|
|Official Title:||High-Intensity Focused Ultrasound (HIFU) for Treatment of Non-nodular and Recurrent Basal Cell Carcinomas of the Skin: Efficacy and Safety.|
|Actual Study Start Date :||March 21, 2022|
|Estimated Primary Completion Date :||December 1, 2024|
|Estimated Study Completion Date :||December 1, 2024|
Experimental: Areas with de-novo or recurrent BCC
Areas with non-nodular de-novo or recurrent BCC area will be treated by high intensity focused ultrasound.
Device: TOOsonix system ONE-M
All selected BCC areas will be treated by high intensity focused ultrasound
- Cure Rate [ Time Frame: 3 months ]Cure rate of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device. Measured as a binary Yes/No output.
- Severity of short term treatment side effects [ Time Frame: 3 months ]Safety profile after treatment of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device. Measured on a 4-point severity score ranging from No side effects (score 1) to Severe side effects (score 4).
- Severity of adverse events [ Time Frame: 12 months ]Any objective adverse effect or event, local or systemic, related to the treatment and the investigational device (wound and course of wound healing, scar formation, instrumental hazards) measured at 6, 9 and 12 months. Measured on a 4-point severity score ranging from No side effects (score 1) to Severe side effects (score 4).
- Cure Rate [ Time Frame: 12 months ]Cure rate of basal cell carcinoma (de novo or recurrences after conventional treatments, two groups) following treatment with the investigational device measured at 6, 9 and 12 months. Measured as a binary Yes/No output.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05133427
|Contact: Joergen V Serup, Professor||+45-2142 4888||Joergen.Vedelskov.Serup@regionh.dk|
|Contact: Gabrielle R Vinding, Phd||+45-2714 4207||GRV@regionsjaelland.dk|
|Copenhagen, Hovedstaden, Denmark, 2400|
|Contact: Joergen V Serup, Professor Joergen.Vedelskov.Serup@regionh.dk|
|Roskilde, Sjaelland, Denmark, 4000|
|Contact: Gabrielle R Vinding, Phd +45-2714 4207 GRV@regionsjaelland.dk|
|Sub-Investigator: Jeanette Kaa, Phd|
|Sub-Investigator: Gregor BE Jemec, Professor|