The Quantum Surgical device
DeviceRobotic platform for needle placement
NCT Number: NCT04230642
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.
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Notify Me18 month and older
All sexes
Interventional
Not applicable
Chu Montpellier, Montpellier, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Robotic platform for needle placement
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
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
Time frame: Through study completion, an average of 1 month
Assessment of the needle placement accuracy (distance from the needle tip to the target)
Time frame: During the procedure
Assessment of the number of needle readjustments to reach the target
Time frame: 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
Quantum Surgical
Industry
Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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