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New device aims to sharpen liver tumor ablation

NCT ID NCT05582018

Knowledge-focused Sponsor: Techsomed Medical Technologies LTD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This pilot study tested a device called BioTraceIO 360, designed to help doctors plan and monitor procedures that destroy liver tumors using heat. The study planned to enroll 30 people with liver cancer, but only 4 participated before it was stopped early. Researchers looked at whether the device's suggestions matched the doctor's own plans and if any device-related side effects occurred.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BioTraceIO 360 device
What this could lead to
If successful, this device could help doctors more accurately plan and monitor liver tumor ablation procedures, potentially improving outcomes.
What could go wrong
This was a very small pilot study (only 4 participants) that was terminated early. The device may not work as intended or may not be better than standard planning methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4 people

The number who actually took part.

Started

Sep 2023

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Scheduled and indicated for standard-of-care liver tumor ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) microwave (MW) energy. * Patient must have at least one prior CT or CECT scan (up to 6 months before enrollment). * Tumor must be visualized on at least one diagnostic imaging modality (MRI or contrast-enhanced CT). * Single tumor, or multiple tumors only if the distance between the ablated tumor and all other tumors allows for distinct separation between the necrotic zones. * Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones. * At least 21 years of age. * Able and willing to give informed consent. Additional inclusion criteria for subgroup: * Single ablation, using a single ablation needle, per tumor. Exclusion Criteria: * Planned ablation includes adjunctive means other than MW energy (e.g., ethanol, hepatic artery embolization, etc.). * Planned ablation includes the use of more than two ablation needles, per tumor * Ablation area cannot be visualized and monitored continuously using ultrasound throughout the entire ablation procedure. * Pregnant or breastfeeding. * Patient judged unsuitable for study participation by the physician for any other reason. * Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period. * Unable or unwilling to give informed consent. Additional exclusion criteria for subgroup: * Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion. * Planned ablation includes repositioning and/or overlapping ablations using a single ablation needle.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma liver cancer Liver Neoplasms metastatic malignant neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma Metastatic liver cancer

Contacts and locations

Locations

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19141, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.