To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver … (NCT04520906) | Clinical Trial Compass
TerminatedNot Applicable
To Evaluate the Safety and Efficacy of Microwave Ablation Therapy in Patients With Primary Liver Cancer
Stopped: Obtaining medical device market approval through the predicate device comparison route.
China61 participantsStarted 2020-12-17
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete tumor ablation rate
Timeframe: 1 month after surgery
Trial details
NCT IDNCT04520906
SponsorSuzhou Hengruihongyuan Medical Technology Co. LTD