Clinical trial · Interventional
NEUWAVE Flexible Probe Study #2
A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung
NCT03713099CI-TRIAL-00045373withdrawnN/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): Changed study design prior to any patients enrolled.
Summary
Brief summary (as posted)
Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation.
Conditions
Conditions (6)
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 Lung | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma, Non-Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasms, Lung | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microwave Ablation
- description
- Microwave ablations will be performed under general anesthesia via a transbronchial approach performed by an interventional pulmonologist or thoracic surgeon.
- interventionNames
- Device: Microwave ablation
Primary outcomes (3)
- measure
- Device User Experience Survey
- timeFrame
- Day of ablation (day 0)
- description
- The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the NEUWAVE microwave ablation system. The questionnaire asks approximately 30 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating physician at the completion of each ablation. A summary of all treating physician responses will be generated at the completion of the study to summarize the overall user experience with the device.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed Informed Consent 2. Patients greater or equal to 18 years of age 3. Performance status 0-2 (Eastern Cooperative Oncology Group classification \[ECOG\]) 4. Willing to fulfill all follow-up visit requirements 5. Medically inoperable and operable secondary soft tissue lesion(s) of the lung 6. A maximum of two ipsilateral soft tissue lesions less than or equal to 2cm in the outer two-thirds of the lung and not closer than 1cm to the pleura. Lesion size must be measured with at least 2-dimensional imaging. Exclusion Criteria: 1. Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related 2. Pregnant or breastfeeding 3. Physical or psychological condition that would impair study participation 4. Patients with uncorrectable coagulopathy at the time of screening 5. Patient with implantable devices, including pacemakers or other electronic implants 6. Prior pneumonectomy or bronchiectasis 7. Severe neuromuscular disease 8. Patient count less than or equal to 50,000/mm cubed 9. ASA (American Society of Anesthesiologists) score of greater than or equal to 4 10. Inability to tolerate anesthesia 11. Expected survival less than 6 months 12. Clinically significant hypertension 13. Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions (however, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted) 14. Endobronchial soft tissue lesions proximal to the segmental airways 15. Imaging findings of active pulmonary infection 16. The patient was judged unsuitable for study participation by the Investigator for any other reason.
References
Publications (0)
Data not yet available
No reference posted for this study.