NCT05698706 (HIFU-BCC) is a NA clinical trial of TOOsonix System ONE-M in Basal Cell Carcinoma, sponsored by Jacek Calik.

Who is sponsoring NCT05698706?

NCT05698706 is sponsored by Jacek Calik.

What drugs are being tested in NCT05698706?

Interventions in NCT05698706: TOOsonix System ONE-M.

What condition does NCT05698706 study?

NCT05698706 studies Basal Cell Carcinoma.

Is NCT05698706 still recruiting?

NCT05698706 is currently status unknown. Last updated 2 February 2023.

Last reviewed 2023-02-02 · How we verify

NCT05698706: HIFU-BCC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma

Status unknown NA Last updated 2 February 2023

What this trial tests

NA trial testing TOOsonix System ONE-M in Basal Cell Carcinoma in 27 participants. Status unknown.

Timeline

14 December 2022

Primary endpoint
14 May 2025

14 May 2025

Quick facts

Lead sponsor	Jacek Calik
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	14 December 2022
Primary completion	14 May 2025
Estimated completion	14 May 2025
Sites	1 location across Poland

Drugs / interventions tested

TOOsonix System ONE-M

Conditions studied

Basal Cell Carcinoma — all drugs for Basal Cell Carcinoma →

Sponsor

Jacek Calik

Who can join

18 and older, any sex, with Basal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Case report: Sequential treatment strategy for advanced basal cell carcinoma in Gorlin-Goltz syndrome: integration of vismodegib, radiotherapy, surgery, and high-intensity focused ultrasound.
Calik J, Oślizło M, Słocka-Romaniuk B, Elsaftawy A, et al · · 2024 · cited 3× · PMID 39091908 · DOI 10.3389/fonc.2024.1428702
High-Intensity Focused Ultrasound in Dermatology: A Review with Emphasis on Skin Cancer Management and Prevention.
Woźniak B, Sobolewski P, Sauer N, Koper M, et al · · 2025 · PMID 41228308 · DOI 10.3390/cancers17213518

Verify or expand the search:

Other trials of TOOsonix System ONE-M

Trials testing the same drug.

NCT05119582 — HIFU Treatment of Cutaneous Neurofibromas in Neurofibromatosis Type 1: Safety and Efficacy · NA · completed

Other recruiting trials for Basal Cell Carcinoma

Currently open trials in the same condition.

NCT07182240 — Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Ba · NA · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT06600165 — Intraoperative Confocal Laser Scanning Microscopy With Use of AI for Optimized Surgical Excision of Basal Cell Carcinoma · recruiting
NCT06384924 — Raman Spectroscopy and Skin Cancer · recruiting
NCT06384053 — Skin Cancer and Hyperthermia and Radiotherapy · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05698706 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Jacek Calik
Last refreshed: 2 February 2023

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/NCT05698706.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing