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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic device | Experimental | Needle placement to the tumor, one time, the day of the ablation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Quantum Surgical device | Device | Robotic platform for needle placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the accuracy of the device | Assessment of the needle placement accuracy (distance from the needle tip to the target) | Through study completion, an average of 1 month |
| Evaluation of the needle readjustments of the device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Guiu, MD | Head of radiology department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Montpellier | Montpellier | 34000 | France | |||
| Gustave Roussy Institut |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Assessment of the number of needle readjustments to reach the target
| 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 | Through study completion, an average of 1 month |
| Villejuif |
| 94000 |
| France |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |