Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement

Hepatic Tumor Clinical Trial

Official title:

Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230642
• Other study ID #: QS-IS-G-H-1901
• Status: Completed
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: February 2, 2021

Study information

• Verified date: February 2021
• Source: Quantum Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Tumor
• Liver Neoplasms

Intervention

Device:
• The Quantum Surgical device
Robotic platform for needle placement

Locations

Country	Name	City	State
France	Chu Montpellier	Montpellier
France	Gustave Roussy Institut	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Quantum Surgical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Evaluation of the needle readjustments of the device	Assessment of the number of needle readjustments to reach the target	During the procedure
Secondary	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