Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03753789
Status:
TERMINATED
Last Update Posted:
2024-01-05
First Post:
2018-10-31
Brief Title:
Ablation Confirmation Study
Sponsor:
Ethicon Inc
Organization:
Ethicon Inc
Study Overview
Official Title:
A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Combined study endpoints with ongoing registry NOLANEU_2017_04
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective single-arm multicenter study that will generate clinical data using the NEUWAVE MicroWave Ablation System with AC Ablation Confirmation software in patients undergoing ablation of a soft tissue liver lesion
Detailed Description:
Prospective single-arm multicenter study that will generate clinical data on 100 adult patients using the NEUWAVE MicroWave Ablation System with AC Ablation Confirmation software in patients undergoing ablation of a soft tissue liver lesion AC software is a computed tomography CT image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System AC imports images from CT scanners for display and processing during ablation procedures to assist physicians in identifying ablation targets assessing optimal ablation probe placement and confirming the adequacy of the ablation margin
All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation
All ablations will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None