Clinical trial · Interventional
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
NCT04520906CI-TRIAL-00091633terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Obtaining medical device market approval through the predicate device comparison route.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| microwave ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-arm
- description
- Subjects will be treated with microwave ablation.
- interventionNames
- Device: microwave ablation
Primary outcomes (1)
- measure
- Complete tumor ablation rate
- timeFrame
- 1 month after surgery
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.