Clinical trial NCT05299606: POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)
Official title: A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects With Oligometastatic Tumors in the Lung
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Neoplasms
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 procedure, subjects with an INR \> 1.5 cannot have the procedure completed that day but may be rescheduled or postponed.
* Subjects medically unable to stop anticoagulants (e.g., rivaroxaban, apixaban, dabigatran, endoxaban) at least 3 days prior to the ablation procedure through 48-72 hours after the procedure.
* Expected survival less than 6 months in the opinion of the investigator and/or treating oncologist.
* Subjects with known or suspected brain metastases.
* Subject has had any radiation (i.e., SBRT or EBRT) to the intended ablation zone.
* Endobronchial tumors proximal to and including the segmental airways.
* Lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned study ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation).
* Systemic therapy (e.g., chemotherapy, targeted drug therapy, or immunotherapy) within 14 days prior to the planned study ablation procedure or those who plan to receive systemic therapy before completing the primary endpoint assessment (30 days post-ablation).

Primary outcomes:
measure: Technique Efficacy
timeFrame: 30 days (-7 to +14 days) post-ablation
Secondary outcomes:
measure: Technical Success
timeFrame: Immediately post-ablation (day 0)
measure: Navigational Success
timeFrame: During navigation (day 0)
measure: Local Tumor Progression
timeFrame: 12-month visit
measure: Local Tumor Progression Free Survival
timeFrame: 12-month visit
measure: Progression Free Survival
timeFrame: 12-month visit
measure: Disease (cancer) Specific Survival
timeFrame: 12-month visit
measure: Overall Survival
timeFrame: 12-month visit
measure: Repeat Ablation Efficacy Rate
timeFrame: 12-month visit
measure: Change in Pulmonary Function Tests (Spirometry I)
timeFrame: 12-month visit
measure: Change in Pulmonary Function Tests (Spirometry II)
timeFrame: 12-month visit
measure: Change in Pulmonary Function Tests (Diffusion Capacity)
timeFrame: 12-month visit
measure: Change in Pulmonary Function Tests (Lung Volume)
timeFrame: 12-month visit
measure: Change in EORTC QLQ-C30
timeFrame: 12-month visit
measure: Change in EORTC QLQ-LC13
timeFrame: 12-month visit
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Farmington
country: United States
facility: UCONN Health
state: Connecticut
city: Minneapolis
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: