POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy)
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ClinicalTrials.gov Identifier: NCT05299606 |
Recruitment Status :
Recruiting
First Posted : March 29, 2022
Last Update Posted : April 24, 2024
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Sponsor:
Ethicon, Inc.
Information provided by (Responsible Party):
Ethicon, Inc.
Tracking Information | |||||||
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First Submitted Date ICMJE | March 3, 2022 | ||||||
First Posted Date ICMJE | March 29, 2022 | ||||||
Last Update Posted Date | April 24, 2024 | ||||||
Actual Study Start Date ICMJE | October 24, 2022 | ||||||
Estimated Primary Completion Date | January 31, 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Technique Efficacy [ Time Frame: 30 days (-7 to +14 days) post-ablation ] Ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) using CT imaging.
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Original Primary Outcome Measures ICMJE | Not Provided | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | POWER Study (Prospective Transbronchial Microwave + Robotic-Assisted Bronchoscopy) | ||||||
Official Title ICMJE | A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects With Oligometastatic Tumors in the Lung | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Lung Neoplasms | ||||||
Intervention ICMJE | Device: 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.
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Study Arms ICMJE | 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.
Intervention: Device: Transbronchial Microwave Ablation
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
145 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Estimated Study Completion Date ICMJE | December 31, 2025 | ||||||
Estimated Primary Completion Date | January 31, 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Sex/Gender ICMJE |
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Ages ICMJE | 22 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, Hong Kong, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05299606 | ||||||
Other Study ID Numbers ICMJE | NEU_2020_03 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Ethicon, Inc. | ||||||
Original Responsible Party | [Redacted] | ||||||
Current Study Sponsor ICMJE | Ethicon, Inc. | ||||||
Original Study Sponsor ICMJE | [Redacted] | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Ethicon, Inc. | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |