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 range18 Years – 75 Years
SexALL
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.
What they're measuring
1
Complete tumor ablation rate
Timeframe: 1 month after surgery
Trial details
NCT IDNCT04520906
SponsorSuzhou Hengruihongyuan Medical Technology Co. LTD