Ablation Confirmation Study
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|ClinicalTrials.gov Identifier: NCT03753789|
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : September 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Liver Liver Cancer Neoplasms, Liver||Device: Microwave Ablation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Study to Evaluate NEUWAVE Microwave Ablation System Using Ablation Confirmation in Patients With a Soft Tissue Liver Lesion|
|Actual Study Start Date :||November 5, 2019|
|Estimated Primary Completion Date :||October 29, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Microwave Ablation
NEUWAVE Microwave Ablation System with AC software for patients undergoing a percutaneous ablation of a soft tissue liver lesion by an interventional radiologist.
Device: Microwave Ablation
NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.
- Percentage of patients where probe repositioning is suggested [ Time Frame: Day of ablation (day 0) ]The percentage of patients for whom probe reposition is suggested by the AC software due to suboptimal initial probe placement.
- Percentage of patients where re-ablation is suggested [ Time Frame: Day of ablation (day 0) ]The percentage of patients for whom re-ablation is suggested by the AC software due to insufficient margins.
- Rate of Adverse Events [ Time Frame: 6 weeks post-ablation ]Patients will be evaluated for device-related or procedure-related AEs and all SAEs from the time of first probe puncture through study completion.
- Technical Success [ Time Frame: Day of ablation (day 0) ]Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an adequate ablative margin). Technical Success will be assessed by the performing physician using AC as a tool, immediately following the ablation procedure.
- Technique Efficacy [ Time Frame: 6 weeks post-ablation ]Technique Efficacy is defined as the complete ablation of the target lesion(s) with an adequate margin. Technique Efficacy will be assessed by the treating physician, at 30 days post-ablation, via imaging.
- Hospital Resource Utilization #1: Time to perform the ablation procedure, [ Time Frame: Day of ablation (day 0) ]The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable): Time to perform the ablation procedure, specifically, a) the time elapsed between loading CT dataset into AC and completion of ablation with probe removal, b) the time elapsed between loading CT dataset into AC to plan for the target ablation and last use of AC to plan for the final ablation, and c) the time elapsed between ablation first probe puncture and removal of the last probe at the completion of the ablation
- Hospital Resource Utilization #2: Length of hospital stay (if applicable) [ Time Frame: 6 weeks post-ablation ]
The Hospital Resource Utilization for ablation patients using AC collects the following information (when applicable):
Length of hospital stay (if applicable)
- Physician Confidence Questionnaire [ Time Frame: Day of ablation (day 0) ]A non-validated 5-point scale (0 meaning 'strongly disagree' and 5 meaning 'strongly agree') questionnaire containing 5 questions for the treating physician asking their confidence in completeness of the ablation before using AC compared to after using AC.
- EORTC QLQ-C30 [ Time Frame: 6 weeks post-ablation ]European Organization for Research and Treatment of Cancer quality of life questionnaire containing 30 questions aimed at cancer patients. Patients will complete this questionnaire at each study visit. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being 'not at all' and 4 being 'very much').
- EORTC QLQ-HCC18 [ Time Frame: 6 weeks post-ablation ]European Organization for Research and Treatment of Cancer quality of life questionnaire containing 18 questions aimed at patients with primary liver cancer. Patients will complete this questionnaire at each study visit. The questionnaire asks patients to rate their responses on a scale from 1-4 (1 being 'not at all' and 4 being 'very much').
- Numeric Pain Rating Scale [ Time Frame: 6 weeks post-ablation ]The Numeric Pain Rating Scale is a questionnaire where the patient reports their pain utilizing a 0-10 scale (where 0 is 'no pain' and 10 is 'maximum pain'). Patients will complete this questionnaire at every study visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753789
|Contact: Erin Meyersemail@example.com|
|Contact: Jaclyn Caliafirstname.lastname@example.org|
|United States, California|
|Loma Linda University Medical Center||Not yet recruiting|
|Loma Linda, California, United States, 92354|
|Cedars-Sinai Medical Center||Not yet recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Ashley Wachsman|
|Principal Investigator: Ashley Wachsman|
|Los Angeles, California, United States, 90095|
|Olives View - UCLA Medical Center||Not yet recruiting|
|Sylmar, California, United States, 91342|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Contact: Matthew Callstrom|
|Principal Investigator: Matthew Callstrom|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10065|
|Contact: Constantinos Sofocleous|
|Principal Investigator: Constantinos Sofocleous|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Bruno Odisio|
|Principal Investigator: Bruno Odisio|
|United States, Wisconsin|
|University of Wisconsin||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Timothy Ziemlewicz|
|Principal Investigator: Timothy Ziemlewicz|