TOOsonix is committed to developing new and innovative treatment modalities in cooperation with leading university hospitals and clinical partners.
Below is a list of on-going clinical trials aimed at developing groundbreaking clinical data that can expand the approved medical use of our products.
On-going Study:
HIFU for Treatment of Non-nodular and Recurrent BCC
Brief 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.
Study Centers:
Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark
Department of Dermatology, Roskilde University Hospital, Region Zealand, Denmark
On-going study:
High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma (HIFU-BCC)
Brief Summary:
The overall objective of the study is to evaluate the safety and efficacy of treatment of Basal Cell Carcinoma (BCC) using a new modality based on high-intensity focused ultrasound (HIFU). BCC is the most common type of skin cancer in Europe, Australia and the US. It accounts for more than 75% of all skin cancer cases in those regions. There are currently more the 14000 BCC cases registrations in Poland every year, and occurrences on a global scale are counted in several millions per year. Given the trend of aging population those numbers will only increase with time. Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective. The investigational device used in the study is a 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 few-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 Center:
Old Town Clinic, Wroclaw, Poland
Completed Study:
HIFU Treatment of Cutaneous Neurofibromas in Neurofibromatosis Type 1: Safety and Efficacy
Brief Summary:
The overall objective is to demonstrate safety and efficacy of HIFU treatment of cutaneous neurofibromas located close to the surface of the skin in patients with the genetic disease Neurofibromatosis Type 1. The study will use a new investigational equipment that has been specially developed for dermatological therapy.
The study includes 20 patients in total distributed between the two centers, each having a minimum of 8 cutaneous neurofibromas eligible for treatment. All participants are adults (over 18 years) of both sexes.
The new treatment method is based on focusing intensive ultrasound just below the skin surface. This creates a very fast localized heating in small and very well-defined volumes containing neurofibroma tissue. This heating destroys or weakens the tissue, and the body’s natural processes will subsequently transport affected cells away through the lymphatic and vascular systems. During the healing-process, the rejected tissue is replaced by new skin cells that are not expected to be fibrous.
Study Centers:
Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark
Department of Dermatology and Venerology, Sahlgrenska University Hopital, Gothenburg, Sweden
Neurofibromatosis Therapeutic Acceleration Program (NTAP), Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Completed Study:
Efficacy Assessment of the High-Frequency High-Intensity Focused Ultrasound as a New Treatment for Actinic Keratosis
Brief Summary:
The objective of this study is to investigate the efficacy of high-intensity focused ultrasound (HIFU) in the treatment of actinic keratosis (AK).
Actinic keratosis is the most common precancerous skin lesion, characterized by the proliferation of atypical epidermal keratinocytes. The progression risk of a single AK lesion to cutaneous squamous cell carcinoma varies widely, with reported annual transformation rates ranging from 0.03% to 20%. Despite the availability of various management options such as topical medications, chemical peels, destructive therapies, and photodynamic therapies, there is growing interest in the use of noninvasive HIFU for AK treatment. HIFU, which operates at frequencies between 500 kHz and approximately 3 MHz, is known for its applications in skin rejuvenation, tightening, and the noninvasive treatment of internal cancers and metastases. At its focal point, HIFU can achieve temperatures around 65°C, sufficient to destroy targeted cancer cells. Previous preclinical and small clinical studies have shown promising results for HIFU in treating dermatological conditions, including AK. This study aims to evaluate the effectiveness of the 20-MHz HIFU as an ablative treatment for AK.
Study Center:
Department of Dermatology, Inselspital, Bern University Hospital, Bern, Switzerland
