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NCT05133427: BCC-HIFU2101
HIFU for Treatment of Non-nodular and Recurrent BCC
NA trial testing TOOsonix system ONE-M in Carcinoma, Basal Cell in 40 participants. Participants enrolled and being followed up; not accepting new ones.
1 March 2026
Quick facts
| Lead sponsor | Joergen Serup |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 21 March 2022 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 2 locations across Denmark |
Drugs / interventions tested
- TOOsonix system ONE-M
Conditions studied
- Carcinoma, Basal Cell — all drugs for Carcinoma, Basal Cell →
Sponsor
Joergen Serup
Who can join
18 and older, any sex, with Carcinoma, Basal Cell. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Immunomodulation and targeted drug delivery with high intensity focused ultrasound (HIFU): Principles and mechanisms.
Ashar H, Ranjan A. · · 2023 · cited 41× · PMID 36965581 · DOI 10.1016/j.pharmthera.2023.108393
Verify or expand the search:
- PubMed search for NCT05133427
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Joergen Serup trials
Trials by the same sponsor.
- NCT05119582 — HIFU Treatment of Cutaneous Neurofibromas in Neurofibromatosis Type 1: Safety and Efficacy · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05133427 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Joergen Serup
- Last refreshed: 3 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05133427.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing