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HIFU for Treatment of Non-nodular and Recurrent BCC

NCT05133427 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-03

No results posted yet for this study

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

DEVICE

TOOsonix system ONE-M

All selected BCC areas will be treated by high intensity focused ultrasound

Sponsors & Collaborators

  • Zealand University Hospital

    collaborator OTHER

  • Joergen Serup

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2026-03-01
Completion
2026-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133427 on ClinicalTrials.gov