NEUWAVE Flexible Probe Study #2
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.
Checked against the public recordLast updated Jun 2, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Ethicon, Inc.
- Interventions being studied
- Device: Microwave ablation
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of HopeDuarte, California
- Mayo ClinicRochester, Minnesota
- New York Presbyterian-Weill Cornell MedicineNew York, New York
- FirstHealth Moore Regional HospitalPinehurst, North Carolina
- Cleveland ClinicCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 2, 2020. Always confirm current availability with the study team.