Feasibility of CT-guided percutaneous needle puncture for kidneys with CASone system

Feasibility of CT-guided percutaneous needle puncture for kidneys with CASone system - Capture

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51258

Enrollment

Registered

2021-07-26

Start date

2022-03-09

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

kidney stones nephrolithiasis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men / Woman > 18 year Indication for PCNL (EAU guidelines 2020)

Exclusion criteria

Exclusion criteria: Untreated urinary tract infection Anatomical abnormalities preventing safe PCNL access or surgical prone positioning Absolute indication for the continuation of anticoagulant medication Potentially malignant kidney tumor Pregnancy

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: The primary endpoint of precise kidney access with CT-based stereotactic navigation CASone system is the technical success rate. This is defined as the successful puncture of the intended calix without needle repositioning.	—

Secondary

Measure	Time frame
Secondary Endpoints: We will evaluate the following parameters: - Accuracy: o Distance between planned target and actual needle tip o Angle between planned needle trajectory and actual needle - Radiation dose in mSv - Procedure time - Number of postoperative imaging investigations during the follow-up period of six weeks - Achievement of stone-free rate - Complications	—

Countries

Netherlands

Outcome results