POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)

Part of paid clinical trials in Stanford, California.

Sponsor
Ethicon, Inc.
Study ID
NCT05299606
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transbronchial Microwave Ablation — DEVICE
    Transbronchial microwave ablation will be performed 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.

Study Details

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.

Key Dates

Start date
Oct 21, 2022
Status verified
Nov 2025
Primary completion
Oct 18, 2024
Completion
Oct 18, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Transbronchial Microwave Ablation
    Transbronchial microwave ablation will be performed 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.

Primary Outcome Measure

Number of Patients Whose Ablation Resulted in Technique Efficacy [ Time Frame: 30 days post-ablation ]

Locations (7)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-
UCONN HealthFarmingtonConnecticut06030-
Minnesota Lung CenterMinneapolisMinnesota55407-
FirstHealth Moore Regional HospitalPinehurstNorth Carolina28374-
Cleveland ClinicClevelandOhio44195-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
MD AndersonHoustonTexas77030-

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Stanford University School of Medicine· Stanford, CAUCONN Health· Farmington, CTMinnesota Lung Center· Minneapolis, MNFirstHealth Moore Regional Hospital· Pinehurst, NCCleveland Clinic· Cleveland, OHUniversity of Pennsylvania· Philadelphia, PA

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