Biopsies. Tissue sampling
Conditions
Interventions
The intervention is the use of the Micromate™ robotic arm for needle guidance in CBCT-guided biopsies. The comparator is the conventional free-hand method, both used in routine clinical care. Patients
Sponsors
St. Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For radiologists:Board-certified interventional radiologists or senior resident/fellows authorized to perform CBCT-guided percutaneous biopsies independently.Familiarity with operation of CBCT imaging and needle guidance systems.Willingness to participate in the study and complete usability questionnaires.For patients:Patients where a biopsy is indicated.Patients that signed the informed consent.
Exclusion criteria
Exclusion criteria: For radiologists:Lack of authorization to perform biopsies independently or under direct supervision.Refusal or inability to complete study documentation and self-assessments.For patients:No informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the accuracy of needle placement, measured as the deviation between planned and actual needle tip location. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include procedure time, number of repositionings, radiation exposure to patient and operator, perceived workload (NASA-TLX), usability (SUS), and cost-effectiveness. | — |
Countries
Netherlands
Contacts
Public ContactP Zappala
St. Antonius Ziekenhuis
Outcome results
None listed