Computer Guided Microwave Liver Ablation

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
NE Scientific INC
Study ID
NCT07226869
Status
Recruiting
Apply to this trial

Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Computer-Assisted Microwave Liver Ablation — DEVICE
    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.

Study Details

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)

Key Dates

Start date
May 8, 2026
Status verified
May 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
84 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Computerized Guidance
    Patients enrolled in this arm will undergo liver cancer microwave ablation under computerized guidance.

Primary Outcome Measure

Local Tumor Progression [ Time Frame: Assessed at each imaging follow-up visit ( at every 3 months, up to 24 months). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Ronal Arellano, MD
[email protected]
857-230-4195
Andrea Borsic, PhD
[email protected]
6172949640
Ronald Arellano, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth HItchcock Medical CenterLebanonNew Hampshire03756
Eric Hoffer, MD
[email protected]
6036670283
Andrea Borsic, PhD
[email protected]
6172949640
Eric Hoffer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MADartmouth HItchcock Medical Center· Lebanon, NH

Related Studies