Hepatic TumorNCT04230642
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
A study testing The Quantum Surgical device in people with Hepatic Tumor, run by Quantum Surgical at 2 sites in France.
Trial summary
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Hepatic Tumor
- What is being tested?
- The Quantum Surgical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- 25 May 2020to 2 Feb 2021
- 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 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is at least 18 years old,
- Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP > 50%),
- Patient who agrees to participate in the evaluation and who has signed the inform consent,
- Patient covered by social security system.
Who cannot join
- Patient unable to undergo general anesthesia,
- Patient unable to tolerate CT contrast agent
- Patient already participating in another clinical study
- Pregnant or breast-feeding woman.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Chu Montpellier
Montpellier, 34000
Gustave Roussy Institut
Villejuif, 94000
About this study
Official title: Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
Read the detailed description
The device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of needle, as well as in verification of needle position during CT guided percutaneous ablation procedures.
After validation of the correct positioning of the needle, the tumor ablation procedure is conducted with a device routinely used by the investigator. The Acquisition of a post-interventional CT-guided image is realized to evaluate adverse events occurrence.
- Conditions
- Hepatic Tumor
- Being tested
- The Quantum Surgical device
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Quantum Surgical deviceDevice
Robotic platform for needle placement
| Study group | Role | What they receive |
|---|---|---|
| Robotic device | Experimental | Needle placement to the tumor, one time, the day of the ablation procedure Receives: Device: The Quantum Surgical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety related to the procedure
Number of Adverse Event(s) that are considered to be major and are attributable to the needle insertion phase of the procedure
Measured: During the procedure
Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
Number of targets reached; the target is considered to have been reached when the needle is positioned accurately enough to allow the next step of the procedure to be carried out
Measured: During the procedure
Secondary outcomes (3)
Evaluation of the accuracy of the device
Assessment of the needle placement accuracy (distance from the needle tip to the target)
Measured: Through study completion, an average of 1 month
Evaluation of the needle readjustments of the device
Assessment of the number of needle readjustments to reach the target
Measured: During the procedure
Evaluation of the safety not related to the procedure
All Adverse Event(s) except those considered major and are attributable to the needle insertion phase of the procedure
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start25 May 2020
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic TumorStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris Guiu, MD, Principal investigator, Head of radiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230642
- Sponsor's protocol ID
- QS-IS-G-H-1901
- Status last verified
- Feb 2021
- First submitted
- 8 Jan 2020
- Last updated
- 4 Feb 2021
- 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 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement
- ClinicalTrials.gov ID
- NCT04230642
- Acronym / sponsor ID
- QS-IS-G-H-1901
- Conditions
- Hepatic Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Quantum SurgicalIndustry (pharma, biotech, devices)
- Study start
- 25 May 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 18 Jan 2020 (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.
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
Detailed description
The device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of needle, as well as in verification of needle position during CT guided percutaneous ablation procedures.
After validation of the correct positioning of the needle, the tumor ablation procedure is conducted with a device routinely used by the investigator. The Acquisition of a post-interventional CT-guided image is realized to evaluate adverse events occurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic device | Experimental | Device: The Quantum Surgical deviceNeedle placement to the tumor, one time, the day of the ablation procedure |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is at least 18 years old,
- Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
- Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP > 50%),
- Patient who agrees to participate in the evaluation and who has signed the inform consent,
- Patient covered by social security system.
Key exclusion criteria (4 listed)
- Patient unable to undergo general anesthesia,
- Patient unable to tolerate CT contrast agent
- Patient already participating in another clinical study
- Pregnant or breast-feeding woman.
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 |
|---|---|---|
| The Quantum Surgical deviceRobotic platform for needle placement | Device | Robotic device |
Primary outcome
Evaluation of the safety related to the procedure
Time frame: During the procedure
Number of Adverse Event(s) that are considered to be major and are attributable to the needle insertion phase of the procedure
Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
Time frame: During the procedure
Number of targets reached; the target is considered to have been reached when the needle is positioned accurately enough to allow the next step of the procedure to be carried out
3 secondary outcomes
Evaluation of the accuracy of the device
Time frame: Through study completion, an average of 1 month
Evaluation of the needle readjustments of the device
Time frame: During the procedure
Evaluation of the safety not related to the procedure
Time frame: Through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- 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.
Boris Guiu, MD principal investigator
Head of radiology department
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Quantum Surgical device in people with Hepatic Tumor, run by Quantum Surgical at 2 sites in France.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the safety related to the procedure (time frame: During the procedure). 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 4 Feb 2021.