Carcinoma, Basal CellBCC-HIFU2101NCT05133427
HIFU for Treatment of Non-nodular and Recurrent BCC
A study testing TOOsonix system ONE-M in people with Carcinoma, Basal Cell, run by Joergen Serup at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- TOOsonix system ONE-M
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesDenmark
- Study dates
- 21 Mar 2022to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of each gender aged 18 years or older at the time of informed consent. There is no upper limit of age.
- Subjects who have received oral and written study information, accepted participation and signed the informed consent document.
- Subjects who are willing and mentally and physically capable to understand and follow the treatment and follow-up schedule including post-treatment care instructions.
- Subjects who are willing to have photographs and images taken of the treated lesions to be used anonymously or coded in evaluations and publications.
- Subjects, who have histologically and clinically verified basal cell carcinoma either as newly diagnosed non-nodular cancer (one group) or as a recurrent cancer in a local site (another group) previously treated with any method practiced in dermatology clinics, hospital or the primary sector. Tumors of thickness more than 2.0 mm measured by ultrasound or OTC are considered of the "nodular" type. Thus, only tumors of thickness 2.0mm and less are included.
Who cannot join
- Subjects who are less than 18 years at the time of informed consent.
- Subject is pregnant or lactating at time of first treatment
- Subjects with extensive, invasive or advanced skin cancer when another method in use such as radiotherapy or Mohs' surgery has priority and offers the patient better opportunity of cure.
- Cancers on anatomical sites where the ultrasound probe cannot be adapted for anatomical reasons
- Any systemic disease that according to investigator's assessment may interfere with the spontaneous course of a skin cancer.
- Any condition predisposing to treatment-related adverse effects or complications from the ultrasound treatment.
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- Subjects with abnormal scar formation
- Subjects with impaired wound healing
- Subjects with the basal cell carcinoma under study located nearby (<5 cm) an implant or a site injected with a dermal filler or paraffin.
- Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Bispebjerg Hospital
Copenhagen, Capital Region, 2400
Roskilde Hospital
Roskilde, Region Sjælland, 4000
About this study
Official title: High-Intensity Focused Ultrasound (HIFU) for Treatment of Non-nodular and Recurrent Basal Cell Carcinomas of the Skin: Efficacy and Safety.
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.
Read more
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
- Being tested
- TOOsonix system ONE-M
- Keywords
- Basal cell carcinoma, BCC, Skin cancer, High intensity focused ultrasound, HIFU, Dermatology
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOOsonix system ONE-MDevice
All selected BCC areas will be treated by high intensity focused ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Areas with de-novo or recurrent BCC | Experimental | Areas with non-nodular de-novo or recurrent BCC area will be treated by high intensity focused ultrasound. Receives: Device: TOOsonix system ONE-M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate
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.
Measured: 3 months
Severity of short term treatment side effects
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).
Measured: 3 months
Secondary outcomes (2)
Severity of adverse events
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).
Measured: 12 months
Cure Rate
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start21 Mar 2022
- Primary completion8 Jan 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joergen Serup
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Responsible party
- Sponsor-investigator, Joergen Serup, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133427
- Sponsor's protocol ID
- CIV-21-06-037051
- Acronym
- BCC-HIFU2101
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Focused Ultrasound (HIFU) for Treatment of Non-nodular and Recurrent Basal Cell Carcinomas of the Skin: Efficacy and Safety.
- ClinicalTrials.gov ID
- NCT05133427
- Acronym / sponsor ID
- BCC-HIFU2101 / CIV-21-06-037051
- Conditions
- Carcinoma, Basal Cell
- Keywords
- Basal cell carcinoma, BCC, Skin cancer, High intensity focused ultrasound, HIFU, Dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Joergen SerupUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Areas with de-novo or recurrent BCC | Experimental | Device: TOOsonix system ONE-MAreas with non-nodular de-novo or recurrent BCC area will be treated by high intensity focused ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects of each gender aged 18 years or older at the time of informed consent. There is no upper limit of age.
- Subjects who have received oral and written study information, accepted participation and signed the informed consent document.
- Subjects who are willing and mentally and physically capable to understand and follow the treatment and follow-up schedule including post-treatment care instructions.
- Subjects who are willing to have photographs and images taken of the treated lesions to be used anonymously or coded in evaluations and publications.
- Subjects, who have histologically and clinically verified basal cell carcinoma either as newly diagnosed non-nodular cancer (one group) or as a recurrent cancer in a local site (another group) previously treated with any method practiced in dermatology clinics, hospital or the primary sector. Tumors of thickness more than 2.0 mm measured by ultrasound or OTC are considered of the "nodular" type. Thus, only tumors of thickness 2.0mm and less are included.
Key exclusion criteria (10 listed)
- Subjects who are less than 18 years at the time of informed consent.
- Subject is pregnant or lactating at time of first treatment
- Subjects with extensive, invasive or advanced skin cancer when another method in use such as radiotherapy or Mohs' surgery has priority and offers the patient better opportunity of cure.
- Cancers on anatomical sites where the ultrasound probe cannot be adapted for anatomical reasons
- Any systemic disease that according to investigator's assessment may interfere with the spontaneous course of a skin cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOOsonix system ONE-MAll selected BCC areas will be treated by high intensity focused ultrasound | Device | Areas with de-novo or recurrent BCC |
Primary outcome
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).
2 secondary outcomes
Severity of adverse events
Time frame: 12 months
Cure Rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOOsonix system ONE-M in people with Carcinoma, Basal Cell, run by Joergen Serup at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.