Clinical trial · Observational
NOLA (NeuWave Observational Liver Ablation) Registry
A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions
NCT04107766CI-TRIAL-00108707terminatedResults 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): Change in Company Strategy
Summary
Brief summary (as posted)
This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.
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)
- label
- Population
- description
- Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
- interventionNames
- Device: Microwave Ablation
Primary outcomes (3)
- measure
- Number of Patients Whose Ablation Resulted in Technical Success
- timeFrame
- Immediately post-ablation (Day 0)
- description
- Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as defined by the performing physician who will make the assessment using CT, MRI, PET, US, and/or X-ray, immediately following the procedure.
- measure
- Number of Patients Whose Ablation Resulted in Technique Efficacy
- timeFrame
- Between 7 days and less than 3 months post-ablation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who underwent or are scheduled to undergo a microwave ablation of one or more liver lesions with the NEUWAVE Microwave Ablation System per the device's Instructions for Use (IFU). 2. Patients with signed informed consent (or waiver approved by IRB/EC) who are willing to comply with the assessment schedule, and willing to have data included in the database. 3. Patients greater than or equal to 22 years old at the time of informed consent (or waiver approved by IRB/EC). Exclusion Criteria: 1. Patients with a life expectancy of less than 1 year, in the opinion of the treating physician. 2. Use of microwave ablation purely as a transection tool, rather than focused liver lesion ablation. 3. Patient is currently participating, or planning to participate, in another NeuWave/Ethicon-funded clinical trial or registry studying microwave ablation in the liver. Note: roll-over patients from previous NeuWave trials are permitted.
References
Publications (0)
Data not yet available
No reference posted for this study.