Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT05698706
Eligibility Criteria:
Inclusion Criteria:
* 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 cancer of thickness not more 2.0 mm measured by ultrasound imaging or histopathological examination.
Exclusion Criteria:
* 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.
* Subjects with abnormal scar formation
* Subjects with impaired wound healing
* Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study
* Subjects undergoing immunosuppressive treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05698706
Study Brief:
Protocol Section:
NCT05698706