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

Carcinoma, Hepatocellular Clinical Trial

Official title:

Pivotal Clinical Study to Establish the Safety and Effectiveness of the Use of BioTraceIO Lite for Assessment of Tissue Damage Following Liver Tissue Ablation Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970212
• Other study ID #: CL000012
• Status: Completed
• Start date: September 24, 2021
• Est. completion date: October 8, 2022

Study information

• Verified date: April 2023
• Source: Techsomed Medical Technologies LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events.

BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of tissue damage created by liver tissue ablation, as part of their overall post-procedure clinical assessment.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 8, 2022
• Est. primary completion date: October 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either RF or MW energy.

2. At least 21 years of age

3. 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 (minimum of 1cm), based on the physician's discretion.

4. Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion.

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

6. Able and willing to give informed consent.

Exclusion Criteria:

1. Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.

2. Subject cannot tolerate/undergo contrast-enhanced CT.

3. Planned ablation includes adjunctive means other than RF or MW energy (e.g., ethanol, hepatic artery embolization, etc.) or overlapping ablations using a single ablation needle.

4. Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.

5. Pregnant or lactating

6. Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.

7. Unable or unwilling to give informed consent.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Metastatic Liver Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	Houston Methodist Hospital	Houston	Texas
United States	Mayo Clinic	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	Stanford Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Techsomed Medical Technologies LTD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Adverse Events	Incidence and severity of device-related adverse events (including serious adverse events (SAE)) occurring between the beginning of the liver tissue ablation procedure and the completion of the T=24hrs contrast-enhanced computed tomography (CECT) scan. There is no comparator for this endpoint.	1 year
Primary	Effectiveness - DICE	Paired comparison of the DICE similarity coefficient, assessed between BioTraceIO Lite, as measured at end of ablation procedure (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24), and the DICE similarity coefficient, assessed between the tissue damage area based on immediately post-procedure CECT (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24).	1 year
Secondary	Sensitivity	Sensitivity of the BioTraceIO Lite at T=0 compared to CECT at T=24hrs.	1 year
Secondary	Precision	Precision of the BioTraceIO Lite at T=0 compared to CECT at T=24hrs.	1 year
Secondary	Questionnaire - Effect of BioTraceIO	The proportion of subjects in whom the treating physician indicates that, if the BioTraceIO Lite results had been available for use in patient management, it would have impacted their follow-up plan for patient management, compared to the CECT alone.	1 year
Secondary	Difference between T=0 and T=24hrs CECT tissue damage	Difference in percentage between tissue damage volume as visualized at T=0 contrast-enhanced computed tomography (CECT) versus tissue damage volume as visualized at T=24hrs CECT.	1 year