Hepatocellular CarcinomaPANORAMA2NCT05641922
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures (PANORAMA2)
A study testing BioTraceIO 360 in people with Hepatocellular Carcinoma and Metastatic Liver Cancer, run by Techsomed Medical Technologies LTD.
Trial 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 Single-center prospective single-arm clinical investigation. Sample size - 10 subjects. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Metastatic Liver Cancer
- What is being tested?
- BioTraceIO 360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Able and willing to give informed consent.
- Additional inclusion criteria for subgroup:
- Single ablation, using a single ablation needle, per tumor.
Who cannot join
- 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.
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- Unable or unwilling to give informed consent.
- Additional exclusion criteria for subgroup:
- 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.
About this study
Official title: Pilot Study to Assess the Safety and Effectiveness of the Use of BioTraceIO 360 for PSM and Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
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
Single-center prospective single-arm clinical investigation.
Sample size - 10 subjects.
- Conditions
- Hepatocellular Carcinoma, Metastatic Liver Cancer
- Being tested
- BioTraceIO 360
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioTraceIO 360Device
Use of the device for planning, monitoring and assessment of liver tissue ablations
| Study group | Role | What they receive |
|---|---|---|
| BioTrace | Experimental | Use of the BioTraceIO 360 device for planning, monitoring and assessment of liver tissue ablations Receives: Device: BioTraceIO 360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Safety
Incidence and severity of device-related adverse
Measured: 1 year
Secondary outcomes (3)
Planning Module
The proportion of subjects in whom the physician has made changes and/or reported increased confidence to the planned ablation procedure after using the BioTraceIO 360 Planning Module compared to without using it.
Measured: 1 year
Monitoring Module
A non-validated qualitative assessment for the physician regarding confidence during the procedure without and with the use of BioTraceIO 360 Monitoring Module if they could have made clinical decisions based on the use of the device.
Measured: 1 year
Assessment Module (1)
A non-validated qualitative assessment on whether there were subjects, in whom the physician indicated that they would have changed the procedure and/or follow-up decision if they could have made clinical decisions based on the visualization of the tumor compared to the necrosis, using the BioTraceIO 360 Assessment Module at the end of the procedure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study startJul 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Withdrawn by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Techsomed Medical Technologies LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641922
- Sponsor's protocol ID
- CL000040
- Acronym
- PANORAMA2
- Status last verified
- Nov 2022
- First submitted
- 29 Nov 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Safety and Effectiveness of the Use of BioTraceIO 360 for PSM and Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
- ClinicalTrials.gov ID
- NCT05641922
- Acronym / sponsor ID
- PANORAMA2 / CL000040
- Conditions
- Hepatocellular Carcinoma, Metastatic Liver Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Techsomed Medical Technologies LTDIndustry (pharma, biotech, devices)
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Single-center prospective single-arm clinical investigation.
Sample size - 10 subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioTrace | Experimental | Device: BioTraceIO 360Use of the BioTraceIO 360 device for planning, monitoring and assessment of liver tissue ablations |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioTraceIO 360Use of the device for planning, monitoring and assessment of liver tissue ablations | Device | BioTrace |
Primary outcome
Effectiveness
Time frame: 1 year
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
Safety
Time frame: 1 year
Incidence and severity of device-related adverse
3 secondary outcomes
Planning Module
Time frame: 1 year
Monitoring Module
Time frame: 1 year
Assessment Module (1)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BioTraceIO 360 in people with Hepatocellular Carcinoma and Metastatic Liver Cancer, run by Techsomed Medical Technologies LTD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.