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Computer Guided Microwave Liver Ablation

NCT07226869 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-11

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the intraoperative use of a computer guidance software can improve the success of liver tumor ablation in adults. The employed software calculates and displays a simulation of the ablation such that the physician can visualize what portion of the target tumor has, and has not been treated at any point during the procedure. The main questions it aims to answer are: 1) Does the use of the computer guidance software reduce the number of times a tumor is incompletely treated. 2) Does the use of the computer guidance software reduce the rate of local tumor recurrence at 2 year follow-up? 3) Was there an increase or a decrease in medical problems for participants after a procedure where the guidance software was used?

Researchers will compare liver tumor treatment using the computer guidance software with an historic control to see if the addition of the guidance software improved the outcomes after an ablation.

Participants will:

Undergo CT-guided microwave ablation treatment of a liver tumor using computer-assisted simulation. Visit the clinic at one month and then every 3 months for blood tests and a contrast-enhanced CT or MRI imaging study (as per standard of care)

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DEVICE

Computer-Assisted Microwave Liver Ablation

Computer-assisted image-processing software used intraoperatively to assist in percutaneous thermal ablation. The software performs segmentation and registration of pre-procedural and intraprocedural imaging, and simulates the expected ablation zone based on probe position, applied energy, and adjacent vascular structures. The output is displayed in 3D multiplanar images to be used by the treating physician to assist in planning, targeting, and intraprocedural decision-making regarding adequacy of ablation coverage. After each ablation activation, the treating physician determines registration accuracy and decides whether any additional ablation is required, based on images of the software estimation of what tissues have and have not been treated.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • NE Scientific INC

    lead INDUSTRY

Principal Investigators

  • Andrea Borsic, PHD · NE Scientific INC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2030-02-28
Completion
2030-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07226869 on ClinicalTrials.gov