Hepatic Tumor
Conditions
Brief 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.
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.
Interventions
DEVICEThe Quantum Surgical device
Robotic platform for needle placement
Sponsors
Quantum Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the safety related to the procedure | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the accuracy of the device | Through study completion, an average of 1 month | Assessment of the needle placement accuracy (distance from the needle tip to the target) |
| Evaluation of the needle readjustments of the device | During the procedure | Assessment of the number of needle readjustments to reach the target |
| Evaluation of the safety not related to the procedure | Through study completion, an average of 1 month | All Adverse Event(s) except those considered major and are attributable to the needle insertion phase of the procedure |
Countries
France
Outcome results
None listed