To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer

Hengruihongyuan Medical Technology

Status

Terminated

Conditions

Hepatocellular Carcinoma

Treatments

Device: microwave ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04520906

MWA1.0

Details and patient eligibility

About

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 of primary liver cancer.

Full 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 through the implementation of prospective, multi-center, single-group target value research. According to the requirements of the trial, 139 patients who were diagnosed with primary liver cancer before surgery and met the inclusion criteria without any exclusion criteria were selected for treatment of their liver cancer with a microwave ablation treatment system, 1 month, 3 months and 6 months after surgery Carry out clinical and imaging follow-up to evaluate the safety of the operation and the effect of tumor ablation.

Enrollment

61 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.