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NCT04970212

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

Completed Last updated 18 April 2023
What this trial tests

trial testing BioTraceIO Lite in Carcinoma, Hepatocellular in 65 participants. Completed in 8 October 2022.

Timeline
24 September 2021
Primary endpoint
8 October 2022
8 October 2022

Quick facts

Lead sponsorTechsomed Medical Technologies LTD
StatusCompleted
Study typeOBSERVATIONAL
Enrollment65
Start date24 September 2021
Primary completion8 October 2022
Estimated completion8 October 2022
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Techsomed Medical Technologies LTD

Who can join

21 and older, any sex, with Carcinoma, Hepatocellular or Metastatic Liver Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Carcinoma, Hepatocellular

Currently open trials in the same condition.

Other Techsomed Medical Technologies LTD trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04970212.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing