NCT05582018

Brief Summary

Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures Multi-center (up to 5 investigational sites) prospective single-arm clinical investigation. Sample size - 30 subjects.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

September 5, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

September 15, 2025

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

October 12, 2022

Last Update Submit

September 7, 2025

Conditions

Hepatocellular CarcinomaMetastatic Liver Cancer

Outcome Measures

Primary Outcomes (2)

  • Effectiveness

    The percentage of patients for whom (1) probe(s) position suggestion provided by the BioTraceIO 360 device is in agreement with the planned probe(s) position, as determined by the physician without the use of the device, or (2) clinically feasible probe(s) positioning suggestion was provided by the BioTraceIO 360 device, in addition to the planned probe(s) position by the physician without the use of the device.

    1 year

  • Safety

    Incidence and severity of device-related adverse

    1 year

Secondary Outcomes (3)

  • Planning Module

    1 year

  • Monitoring Module

    1 year

  • Assessment Module (1)

    1 year

Other Outcomes (4)

  • Assessment Module (2)

    1 year

  • Accuracy

    1 year

  • Sensitivity

    1 year

  • +1 more other outcomes

Study Arms (1)

BioTrace

EXPERIMENTAL

Use of the BioTraceIO 360 device for planning, monitoring and assessment of liver tissue ablations

Device: BioTraceIO 360

Interventions

BioTraceIO 360DEVICE

Use of the device for planning, monitoring and assessment of liver tissue ablations

BioTrace

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Single ablation, using a single ablation needle, per tumor.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 17, 2022

Study Start

September 5, 2023

Primary Completion

April 15, 2024

Study Completion

May 15, 2024

Last Updated

September 15, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)