Clinical trial · Interventional
Ablation Confirmation Study
A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion
NCT03753789CI-TRIAL-00072784terminatedN/AResults postedClinicalTrials.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): Combined study endpoints with ongoing registry (NOLA/NEU\_2017\_04)
Summary
Brief summary (as posted)
Prospective, single-arm, multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC (Ablation Confirmation) software in patients undergoing ablation of a soft tissue liver lesion.
Conditions
Conditions (3)
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 of the Liver | Malignant Liver Neoplasm | ALIAS | 0.90 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasms, Liver | Liver Neoplasm | 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
- NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.
- interventionNames
- Device: Microwave Ablation
Primary outcomes (2)
- measure
- Percentage of Lesions Where Probe Repositioning is Suggested
- timeFrame
- Day 0
- measure
- Percentage of Lesions Where Re-ablation is Suggested
- timeFrame
- Day 0
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. A patient with at least one soft-tissue liver lesion less than or equal to 5cm undergoing microwave ablation using the NEUWAVE Microwave Ablation System. Note: a patient cannot have more than 3 lesions ablated during the procedure. 2. Intent to use Ablation Confirmation software (any AC software version permitted) during the ablation procedure. 3. Written Informed Consent to voluntarily participate in the study, follow CT scan schedule, and authorize the transfer of his/her data to the Sponsor 4. Patients greater than or equal to 22 years of age 5. Performance status 0-2 (Eastern Cooperative Oncology Group \[ECOG\]) classification 6. Class A or B functional hepatic reserve based on the Child-Pugh score. 7. Lesion must be visualized by non-contrast enhanced CT scan or the patient must tolerate contrast and meet institutional guidelines for contrast use based on glomerular filtration rate (GFR). Exclusion Criteria: 1. Active bacterial infection or fungal infection on the day of the ablation. 2. Patients with implantable pacemakers or other electronic implants. 3. Platelet count less than 50,000/mm cubed. 4. Patients with uncorrectable coagulopathy at the time of ablation. 5. Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test, per site's SOC). 6. Physical or psychological condition which would impair study participation. 7. ASA (American Society of Anesthesiologists) score of great or equal to 4. 8. Use of hydrodissection. 9. Systemic chemotherapy or radiation therapy for the liver, within 30 days prior to the study ablation procedure. 10. INR greater than 1.8. 11. Patient has participated in an investigational clinical study within 30 days of the screening visit for this study. 12. Patient judged unsuitable for study participation by the performing physician for any other reason.
References
Publications (0)
Data not yet available
No reference posted for this study.