NEUWAVE Flexible Probe Study #2
Withdrawn before enrolling · Not applicable
Conditions studied: Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma
In brief
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.
Key facts
- Study ID
- NCT03713099
- Run by
- Ethicon, Inc.
- People needed
- 0
- Starts
- 2020-07-31
- Expected to finish
- 2022-03-31
- Last updated by the study team
- 2020-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed Informed Consent
- Patients greater or equal to 18 years of age
- Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG])
- Willing to fulfill all follow-up visit requirements
- Medically inoperable and operable secondary soft tissue lesion(s) of the lung
- 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.
You may not qualify if…
- Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
- Pregnant or breastfeeding
- Physical or psychological condition that would impair study participation
- Patients with uncorrectable coagulopathy at the time of screening
- Patient with implantable devices, including pacemakers or other electronic implants
- Prior pneumonectomy or bronchiectasis
- Severe neuromuscular disease
- Patient count less than or equal to 50,000/mm cubed
- ASA (American Society of Anesthesiologists) score of greater than or equal to 4
- Inability to tolerate anesthesia
- Expected survival less than 6 months
- Clinically significant hypertension
- 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)
- Endobronchial soft tissue lesions proximal to the segmental airways
- Imaging findings of active pulmonary infection
- The patient was judged unsuitable for study participation by the Investigator for any other reason.
Where it is running
- City of Hope — Duarte, California, United States
- Mayo Clinic — Rochester, Minnesota, United States
- New York Presbyterian-Weill Cornell Medicine — New York, New York, United States
- FirstHealth Moore Regional Hospital — Pinehurst, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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