Study Stopped
Obtaining medical device market approval through the predicate device comparison route.
To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
Prospective, Multicenter, Single-group Target Study to Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
1 other identifier
interventional
61
1 country
13
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 of primary liver cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started Dec 2020
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 20, 2020
CompletedStudy Start
First participant enrolled
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedJuly 1, 2025
June 1, 2025
1.3 years
August 18, 2020
June 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complete tumor ablation rate
the percentage of complete ablation subjects for all subjects undergoing ablation surgery. Complete ablation: Follow up by MRI scan 1 month after surgery, the area where the tumor is located is in the low-density arterial phase without enhancement; if the tumor is followed up by MRI scan 1 month after surgery, there is enhancement in the local arterial phase within the tumor lesion, which suggests that the tumor remains. The tumor could be treated by re-ablation; if there is still residual tumor in MRI scan 1 month after the second ablation, it is judged as incomplete ablation.
1 month after surgery
Secondary Outcomes (2)
First complete tumor ablation rate
1 month after surgery
Complete ablation rate of lesions
1 month after surgery
Study Arms (1)
single-arm
EXPERIMENTALSubjects will be treated with microwave ablation.
Interventions
ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
Ruijin Hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200120, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The Central Hospital of Lishui City
Lishui, Zhejiang, 323000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaojun Teng, Doctor
Zhongda Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2020
First Posted
August 20, 2020
Study Start
December 17, 2020
Primary Completion
April 6, 2022
Study Completion
April 1, 2023
Last Updated
July 1, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share