Status:
TERMINATED
To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
Lead Sponsor:
Suzhou Hengruihongyuan Medical Technology Co. LTD
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Through the implementation of prospective, multi-center, single-group target value research to verify the safety and effectiveness of the microwave ablation treatment system for the ablation treatment...
Detailed Description
The safety and effectiveness of the microwave ablation treatment system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. for the ablation treatment of primary liver cancer is verified ...
Eligibility Criteria
Inclusion
- Pathological and/or clinical diagnosis confirmed as primary liver cancer (hepatocellular carcinoma).
- Single tumor with maximum diameter ≤ 5cm ; or tumors number ≤ 3 with maximum diameter ≤ 3cm.
- No invasion of blood vessels, gallbladder, adjacent organs and distant metastasis.
- Child-Pugh class A or B classification, or meet the standard after treatment.
- Able to understand the content of clinical trials, voluntarily participate in the trial and sign informed consent.
Exclusion
- Pregnant or breastfeeding, or preparing to become pregnant during the trial.
- Participating in clinical trials of other devices or drugs.
- Uncorrectable coagulation dysfunction (after corrective treatment, the PT exceeds the normal control value by more than 3s).
- PLT \<50x109/L.
- Intractable massive ascites.
- Cachexia.
- MRI examination is contraindicated or the investigator judges it is not suitable for MRI examination.
- Patients with bleeding from esophageal (fundus of stomach) varicose veins 1 month before surgery.
- Patients with impaired consciousness or unable to cooperate with treatment.
- The investigator judged that it is not suitable to participate in clinical trials.
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04520906
Start Date
December 17 2020
End Date
April 1 2023
Last Update
July 1 2025
Active Locations (13)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008