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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05451160
Eligibility Criteria:
Inclusion Criteria:
1. The age of the patient is between 18-80 years old, and the gender is not limited.
2. For clinically diagnosed liver tumors, the diameter of a single tumor is less than or equal to 5cm; for multiple tumors: the number of tumors is not more than 3, and the largest tumor diameter is less than or equal to 3cm.
3. Patient is able to take care of himself, and ECOG performance status is between 0 and 2 points.
4. Liver function classification Child-Pugh A or B.
5. Expected survival period ≥ 6 months.
6. Patient is able to understand and comply with the trial protocol, and sign the informed consent.
Exclusion Criteria:
1. It is less than 30 days after the end of chemotherapy, radiotherapy, immunotherapy, or targeted therapy.
2. Within 3 months after ablation, patients need to continue treatment with chemotherapy, radiation therapy, immunotherapy, targeted therapy, surgery, or other minimally invasive modalities.
3. patients with severe infectious diseases such as bacteremia and toxemia.
4. patients with uncorrectable coagulation dysfunction (PLT\<40xl09/L).
5. patients with severe heart, brain, lung and other diseases, and patients with severe arrhythmia.
6. patients with implanted artificial hearts, lungs, internal pulse regulators or wearable medical electronic devices such as electrocardiography.
7. Patients with a history of epilepsy.
8. Patients with acute myocardial infarction within 6 months.
9. Pregnant and lactating women and those who plan to become pregnant within one year.
10. Those who are allergic to ultrasound, CT or MRI contrast agents.
11. Those who are contraindicated in general anesthesia.
12. Those who have participated in clinical trials of any drug or medical device within the first 3 months of the group.
13. The researchers believe that there are other factors that are not suitable for inclusion or that affect the participation of subjects in the study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05451160
Study Brief:
Protocol Section:
NCT05451160