Navigation for percutaneous liver ablation

Navigation for percutaneous liver ablation - Navigation for percutaneous liver ablation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57277

Enrollment

Registered

2025-02-03

Start date

2025-03-19

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver lesions liver metastases

Interventions

A semi-automatically segmented 3D model from the pre-procedural CT scan, is&nbsp

registered with our EM-field. To achieve this, sensors are sticked to the&nbsp

patient*s skin during the CT scan and will stay in place during the entire&nbsp

procedure. By placing an EM-tracked, rigid cannula onto the ablation antenna we&nbsp

can visualize the ablation antenna relative to the anatomy and the liver&nbsp

lesions. Besides, EM-tracked ultrasound facilitates orientation during the&nbsp

antenna placing procedure. The antenna is placed during breath hold to minimize&nbsp

the influence of the breathing on the position of the liver.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years; - Patient or legal representative provides written informed consent form; - Patient is scheduled for percutaneous liver ablation.

Exclusion criteria

Exclusion criteria: - Ferro-magnetic implants in the abdominal or pelvic area that could influence  EM tracking; - Pacemaker.

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the feasibility of our in-house developed navigation system for percutaneous liver ablation. The study is considered feasible when 70% of the navigations are successful. A navigation is successful when the ablation antenna is accurately visualized with respect to a registered 3D model of the target lesion. An error between the determined position in the 3D model and the actual position of the ablation needle as determined by a standard verification CT scan of less than 10 mm is regarded accurate. 10 mm is regarded as sufficient, as the total volume of the ablation zone is 3 cm or larger.	—

Measure

Time frame

The main study endpoint is the feasibility of our in-house developed navigation system for percutaneous liver ablation. The study is considered feasible when 70% of the navigations are successful. A navigation is successful when the ablation antenna is accurately visualized with respect to a registered 3D model of the target lesion. An error between the determined position in the 3D model and the actual position of the ablation needle as determined by a standard verification CT scan of less than 10 mm is regarded accurate. 10 mm is regarded as sufficient, as the total volume of the ablation zone is 3 cm or larger.

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Secondary

Measure	Time frame
• To evaluate easiness of use and support for decisiveness during surgery using stand-ardized System Usability Scale (SUS) questionnaires. • To evaluate the time of all study-related actions during the surgery. • To evaluate the accuracy of the registration from the pre-procedural CT to the EM-field with the target registration error (distance tumor center CT - tumor center EM). • To evaluate the antenna tracking accuracy, which is defined as the distance between the antenna in the US image and in the EM field.	—

Measure

Time frame

• To evaluate easiness of use and support for decisiveness during surgery using stand-ardized System Usability Scale (SUS) questionnaires. • To evaluate the time of all study-related actions during the surgery. • To evaluate the accuracy of the registration from the pre-procedural CT to the EM-field with the target registration error (distance tumor center CT - tumor center EM). • To evaluate the antenna tracking accuracy, which is defined as the distance between the antenna in the US image and in the EM field.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)