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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Microwave and Radiofrequency Ablation for Liver

NCT02539212

Hepatocellular Carcinoma

COMPLETED NA

Microwave Ablation Simultaneously Combined With Lenavatinib for Recurrent Hepatocellular Carcinoma

NCT05444478

Hepatocellular Carcinoma Microwave Ablation Liver Cancer +2 more

RECRUITING NA

Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma

NCT06086002

Hepatocellular Carcinoma

UNKNOWN NA

Ablation Combined With PD-1 in HCC: Phase II Study

NCT04652440

Hepatocellular Carcinoma

UNKNOWN PHASE1/PHASE2

The Efficacy and Safety of EOB-MRI Guided Microwave Ablation for Early HCC: A Multicenter, Prospective, Observational Study

NCT06096896

Early Hepatocellular Carcinoma

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, multi-center, single-group target value

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single-arm

Subjects will be treated with microwave ablation.

Group Type EXPERIMENTAL

microwave ablation

Intervention Type DEVICE

ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

microwave ablation

ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No