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Patients who underwent a Microwave Ablation at a participating institution and a NeuWave generator was utilized.

The NEUWAVE System supports target ablation or linear coagulation in surgical liver resection procedures. The System offers a versatile probe portfolio, multi-probe synchrony and CO2 cooling to help control the shape, size and burn pattern of your ablations.

NeuWave Microwave Ablation System

David A Iannitti, MD

To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed.

To prospectively collect and evaluate pre-operative, intra-operative, and post-operative variables for all patients undergoing surgical microwave ablation. All patients who have a surgical microwave ablation with the Neuwave system will be added to the database after their treatment and procedures have been completed. All data points will be collected from the electronic medical records (EMR) (office visit notes, operative notes, follow-up visits, CT scans, etc.). The collected data points will be utilized to study outcomes such as local/regional reoccurrences and distant occurrences related to hepatic tumor(s), whether there was complete destruction, residual disease/incomplete destruction, or recurrence at the ablation site. Overall-complications, length of stay, readmission rates, and any additional outcomes data that is relevant to MWA and improving surgical outcomes will also be collected.

There are various Microwave Ablation (MWA) systems available that are utilized at the study locations to treat hepatic tumors. For this study, the focus is on subjects treated with the Certus 140TM system from NeuWave Medical®. Certus 140TM microwave generator possesses a 2.45 gigahertz (GHz) operating frequency and can power up to 140 watts. It can deliver microwave energy through three distinct channels simultaneously through a single system and uses three distinct antenna types (LK, SR, PR). It also contains a CO2-based cooling system that helps limit the temperature of the handle and cable. It is compatible with a variety of probes (LK, SR and PR antenna) and offers two modes, Ablation mode and Surgical mode. The Ablation mode is used for ablating a substantial target for several minutes until the object of the ablation is necrotic. Surgical Mode is used to ablate or coagulate a target for shorter periods of time while frequently moving the probe in a technique known as "planar coagulation."

Current data and manufacturer guidelines for recommended ablation energy outputs for microwave ablation systems are obtained via ex vivo and animal models with tissues that exhibit different properties of energy transference than in vivo human tissues, particularly, human hepatic solid tumors. The objective is to prospectively assess the thermodynamics of microwave ablation energy in this context, specifically through the creation of power/time curves to predict future ablation volumes through single applications of MWA energy per lesion.

Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics

Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Solid Tumors

The primary objective is to prospectively assess the thermodynamics of microwave ablation energy in this context, specifically through the creation of power/time curves to predict future ablation volumes through single applications of MWA energy per lesion.

Investigator to describe the appearance of the liver intraoperatively

Investigator to describe if any extrahepatic disease is present

Investigator to describe if any chronic liver disease is present

Ablation dimensions as assessed by post-operative cross-sectional imaging using the x-axis along the length of the antenna tract and y-axis perpendicular to the antenna tract

Disease recurrence defined as the radiologic presence of disease present at the index location at the 4-week follow up postoperative cross-sectional imaging

New lesions noted on CT (as above) and their measurements

Time from first incision until final skin closure

Time from hospital admission until hospital discharge

Percentage of patients who were readmitted to the hospital after MWA

Percentage of patients who experienced a complication 30 following MWA

Percentage of patients who experienced a complication 90 following MWA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics	NCT05471596	Liver Diseases	NeuWave Microwa...	18 Years -	Wake Forest University Health Sciences
Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics	NCT05471596	Liver Diseases	NeuWave Microwa...	18 Years -	Wake Forest University Health Sciences

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