POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy) (NCT05299606) | Clinical Trial Compass
TerminatedNot Applicable
POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)
Stopped: Change in Sponsor strategy
United States12 participantsStarted 2022-10-21
Plain-language summary
This is a prospective, multicenter, single-arm study on transbronchial microwave ablation using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The primary endpoint is Technique Efficacy, assessed 30-days post-ablation via CT imaging.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
* Signed informed consent.
* Subjects greater or equal to 22 years old.
* Performance status 0-2 (Eastern Cooperative Oncology Group classification (ECOG).
* Willing to fulfill all follow-up visit requirements.
* Subjects with at least one oligometastatic lung tumor where the primary tumor is controlled (in the opinion of the investigator or treating oncologist).
* Oligometastatic lung tumor(s) planned to be ablated in the outer two-thirds of the lung and not closer than 1cm to the pleura.
EXCLUSION CRITERIA:
* Pregnant or breastfeeding.
* Subjects with thoracic implantable devices, including pacemakers or other electronic implants.
* 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).
* Prior pneumonectomy.
* Severe bronchiectasis (with FEV1 \<30%) or disease deemed to be too severe in the opinion of the investigator.
* Platelet count ≤ 50,000/mm3.
* Subjects with uncorrectable coagulopathy at time of screening.
* Subjects medically unable to stop anti-platelet agents (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days prior to the procedure through 48-72 hours after the procedure.
* Subjects medically unable to stop warfarin at least 3-5 days prior to the ablation procedure, or until INR \< 1.5, through 48-72 hours after the procedure. On the day of the proc…
What they're measuring
1
Number of Patients Whose Ablation Resulted in Technique Efficacy