An interventional study of The Quantum Surgical device in Hepatic Tumor, sponsored by Quantum Surgical. Completed at 2 sites in France. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Quantum Surgical · Not applicable, Interventional, and Treatment
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.
3,251 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's enrollment of 22 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Quantum Surgical is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Needle placement to the tumor, one time, the day of the ablation procedure
Device: The Quantum Surgical device
Robotic platform for needle placement
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
Time frame: 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
Time frame: During the procedure
Evaluation of the accuracy of the device
Assessment of the needle placement accuracy (distance from the needle tip to the target)
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 1 month
Plan to share: No
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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