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Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures

NCT04970212 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2023-04-18

No results posted yet for this study

Summary

Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events.

Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).

Conditions

  • Carcinoma, Hepatocellular
  • Metastatic Liver Cancer

Interventions

DEVICE

BioTraceIO Lite

The BioTraceIO software will analyze the ultrasound images, and provide the physician with an estimated tissue damage map.

Sponsors & Collaborators

  • Techsomed Medical Technologies LTD

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2022-10-08
Completion
2022-10-08
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04970212 on ClinicalTrials.gov