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OpenTrials
Completed

NCT Number: NCT04230642

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

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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Key information

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Montpellier, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Quantum Surgical device

Device

Robotic platform for needle placement

Primary outcomes

  1. Evaluation of the safety related to the procedure

    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

  2. Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached

    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

Secondary outcomes

  1. Evaluation of the accuracy of the device

    Time frame: Through study completion, an average of 1 month

    Assessment of the needle placement accuracy (distance from the needle tip to the target)

  2. Evaluation of the needle readjustments of the device

    Time frame: During the procedure

    Assessment of the number of needle readjustments to reach the target

  3. Evaluation of the safety not related to the procedure

    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

Sponsors and collaborators

Lead sponsor

Quantum Surgical

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2020
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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