Clinical trial · Interventional
Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
A Study to Evaluate the Safety and Effectiveness of Microwave Ablation in Patients With Hepatocellular Carcinoma in Korea
NCT03586050CI-TRIAL-00079098completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm, non-randomized, single center study to evaluate ablation, oncologic outcomes and safety in the treatment of hepatocellular carcinoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Hepatocellular | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| 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
- Microwave Ablation
- description
- All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories
- interventionNames
- Device: Microwave ablation
Primary outcomes (1)
- measure
- Number of Participants Whose Ablation Resulted in Technical Success
- timeFrame
- Post ablation procedure (Day 0) up to 4 days
- description
- Number of participants whose ablation resulted in technical success were reported. Technical success was defined as complete tumor ablation with adequate or insufficient margin, based on contrast-enhanced Magnetic resonance imaging (MRI) and Computed scans immediately following the ablation procedure on Day 0 evaluated by the independent reviewer and principle investigator (PI) based on the response to the question "Confirm outcome of ablation".
Secondary outcomes (16)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed hepatocellular carcinoma, tumor size of more than 2 cm and up to 5cm, single location, Barcelona Clinic Liver Cancer (BCLC) Stage A based on imaging and biopsy confirmation 2. Primary hepatocellular carcinoma or recurrent hepatocellular carcinoma which was previously treated with ablation or surgical resection only; 3. Scheduled for microwave ablation of the liver; 4. Performance status 0-1 (Eastern Cooperative Oncology Group classification); 5. Functional hepatic reserve based on the Child-Pugh score (Class A or B); 6. American Society of Anesthesiologists (ASA) score \< 3; 7. Given voluntary, written informed consent to participate in this study and has authorized the transfer of his/her information to the Sponsor, and willing to comply with study-related evaluation and treatment schedule; 8. At least 19 years of age Exclusion Criteria: 1. Active bacterial infection or fungal infection; 2. Systemic administration of steroids, including herbal supplements that contain steroids, within 30 days prior to the study procedure; 3. Chemotherapy or radiation therapy for hepatocellular carcinoma may not be performed for 30 days prior to the study procedure; 4. Subject with implantable pacemakers or other electronic implants; 5. Planned/ scheduled liver surgery. 6. Subject with a platelet count of less than 20,000/mm3; 7. Subject with an INR greater than 1.5; 8. Subject with renal failure on renal dialysis; 9. Scheduled concurrent procedure other than microwave ablation in the liver; 10. Pregnant or lactating; 11. Physical or psychological condition which would impair study participation; 12. Participation in any other clinical study concurrently or within the last 3 months; 13. The subject is judged unsuitable for study participation by the Investigator for any other reason; 14. Unable or unwilling to attend follow-up visits and examinations.
References
Publications (0)
Data not yet available
No reference posted for this study.