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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05077033
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed, previously untreated cutaneous basal cell carcinoma located in head and neck region.
* Solitary tumors, with largest diameter up to 3 cm, in the region where curative surgery is feasible.
* Age 18-years or older.
* Life expectancy \> 3 months.
* Physical performance in accordance with the Karnofsky scale ≥ 70 or \< 2 in accordance with World Health Organization (WHO) scale.
* The patient must be capable of understanding the treatment procedure and possible adverse events, which may arise during treatment.
* The patient must be capable of signing the informed consent to participate in the clinical study (voluntary and conscientious consent after education).
* Prior to inclusion in the trial, the patient must be presented at a multidisciplinary advisory team meeting.
Exclusion Criteria:
* Known malignancy elsewhere in/on the body.
* Lesions not suitable for treatment with GET (invasion into the bone, infiltration of large vessels).
* A life-threatening infection and/or severe heart failure and/or liver failure and/or other life-threatening systemic diseases.
* Significantly reduced lung function, which requires the determination of DLCO. Patients should not be treated if DLCO is abnormal.
* Treatment with immunosuppressive drugs, steroids and other drugs that would affect poor wound healing.
* Age under 18-years.
* Major disruptions in the coagulation system (who does not respond to the standard therapy - replacement of vitamin K or freshly frozen plasma).
* A chronic decline in the kidney function (creatinine \> 150 µmol/L).
* Epilepsy.
* Pregnancy and breast-feeding.
* The patient's incapability of comprehending the purpose or course of the trial, or not agreeing to be included in the trial.
* Patients unwilling or unable to comply with the protocol requirements and scheduled visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05077033
Study Brief:
Protocol Section:
NCT05077033