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Completed

NCT Number: NCT05471596

Prospective Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Health

Charlotte, North Carolina, 28203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with hepatic tumors (Age >18 years or older)
  • Treatment included microwave ablation with the Neuwave system

Exclusion criteria

  • Age <18
  • Benign Tumors
  • Patients whose initial treatment plan did not include MWA, although they later received one (rescue MWA)
  • Multiple tumors with distances or geometric relations rendering volumetrics incalculable or unduly confounded

Treatment and study plan

NeuWave Microwave Ablation System

Device

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.

Primary outcomes

  1. Prospective Power/Time Analysis of In Vivo Laparoscopic Microwave Ablation Thermodynamics in Hepato-Pancreato-Biliary Sold Tumors Utilizing a Single Generator at a Single Surgical Center

    Time frame: Year 2

    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.

Secondary outcomes

  1. Liver appearance

    Time frame: Baseline

    Investigator to describe the appearance of the liver intraoperatively

  2. Presence of extrahepatic disease

    Time frame: Baseline

    Investigator to describe if any extrahepatic disease is present

  3. Chronic Liver Disease Evidence

    Time frame: Baseline

    Investigator to describe if any chronic liver disease is present

  4. Number of Lesions

    Time frame: Baseline

    Number of lesions present

  5. Lesion location

    Time frame: Baseline

    Location (segment) of each lesion

  6. Size of Lesion

    Time frame: Baseline

    Size of each lesion

  7. Amount of Power used

    Time frame: Baseline

    Power (W) used to ablate each lesion

  8. Amount of Time used

    Time frame: Baseline

    Time (min) used to ablate each lesion

  9. Distance between lesions

    Time frame: Baseline

    The distance between liver lesions

  10. Ablation Dimensions

    Time frame: day 90

    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

  11. Disease Recurrence Rate

    Time frame: week 4

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

  12. Number of New lesions

    Time frame: day 90

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

  13. Radiographic liver appearance

    Time frame: day 90

    Liver appearance on CT

  14. Radiographic extrahepatic disease

    Time frame: day 90

    Presence of extrahepatic disease on CT

  15. Tumor measurement

    Time frame: Baseline

    Index tumor diameter and volume

  16. Ablation Time

    Time frame: Baseline

    The time at which ablation occurred

  17. Ablation Energy output

    Time frame: Baseline

    Energy output from ablation

  18. Ablation Margins

    Time frame: day 90

    Ablation margins

  19. Operative Time Amount

    Time frame: Baseline

    Time from first incision until final skin closure

  20. Length of Stay

    Time frame: up to 90 days

    Time from hospital admission until hospital discharge

  21. Readmission Rates

    Time frame: day 90

    Percentage of patients who were readmitted to the hospital after MWA

  22. 30 day complication rate

    Time frame: day 30

    Percentage of patients who experienced a complication 30 following MWA

  23. 90 day complication rate

    Time frame: day 90

    Percentage of patients who experienced a complication 90 following MWA

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Acronym: MWA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2022
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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