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NCT04970212 · ClinicalTrials.gov registry record
Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
A clinical trial of Carcinoma, Hepatocellular and Metastatic Liver Cancer, sponsored by Techsomed Medical Technologies.
- Completed
- Registry status
- 65
- Enrollment target
- 6
- Study locations
NCT04970212 is a study of Carcinoma, Hepatocellular and Metastatic Liver Cancer that has completed, run by Techsomed Medical Technologies. The registered enrollment target is 65 participants, below the 610-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 6 states.
The verdict
NCT04970212, a study of Carcinoma, Hepatocellular and Metastatic Liver Cancer, has completed, sponsored by Techsomed Medical Technologies.
- COMPLETED
- Registry status
- 65 participants
- Enrollment target
- 6
- Study locations
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 Studied
Interventions
- DEVICE BioTraceIO Lite
Study Locations (6)
Arizona
- Mayo Clinic - Phoenix
California
- Stanford Medicine - Stanford
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
Ohio
- University Hospitals Cleveland - Cleveland
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2022-10-08 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04970212
The ClinicalTrials.gov registry entry for NCT04970212 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 610-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (89% lower). The listed sponsor is Techsomed Medical Technologies, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Carcinoma, Hepatocellular appearing as the primary indexed condition, and to 1 intervention - of which BioTraceIO Lite is the first listed.
NCT04970212 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Arizona, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04970212 about?
NCT04970212 is a clinical study titled "Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures". 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 ...
What is the current status of trial NCT04970212?
This trial is currently completed. The enrollment target is 65 participants. The study started on 2021-09-24. Estimated completion is 2022-10-08.
What conditions does trial NCT04970212 study?
This clinical trial studies the following conditions: Carcinoma, Hepatocellular, Metastatic Liver Cancer.
What interventions are being tested in trial NCT04970212?
The interventions under investigation include: BioTraceIO Lite (DEVICE).
Who is sponsoring clinical trial NCT04970212?
This trial is sponsored by Techsomed Medical Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04970212 being conducted?
This trial has 6 study locations across Arizona, California, Massachusetts, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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