Prospective, Randomized, Controlled, Parallel Group Study to Compare a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Puncture accuracy
Study Overview
Brief Summary
In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture Cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).
Detailed Description
Computed tomography (CT)-guided interventions for diagnostic and therapeutic purposes are standard approaches in clinical routine (e.g. in patients with low back pain). Numerous CT needle navigation systems have been developed with the aim to improve accuracy (and thus safety) of punctures while decreasing radiation exposure and procedure time. Their usability in clinical routine is limited either because of high sensitivity to interference, high expenses, bulkiness, or incompatibly with daily clinical practice and thus increasing procedure time and workflow complexity. The Puncture Cube® takes into account all these requirements. Furthermore, in an in vitro-phantom study (study submitted for publication), punctures with the Cube were found to be faster and more accurate compared to the free-hand conventional method.
In a prospective, randomized, controlled, parallel group study the accuracy, intervention time and radiation dose of CT-guided punctures using the Puncture Cube® will be compared to the conventional free-hand method in patients requiring a percutaneous diagnostic or therapeutic CT-guided intervention for lumbar pain (facet joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients requiring a percutaneous therapeutic CT-guided intervention for
- •lumbar pain (joint-, nerve root-, epidural infiltrations at the lumbar/lumbosacral level)
- •age ≥ 18 years
- •Signed informed consent prior to intervention
Exclusion Criteria
- •Patients suffering from severe obesity (BMI > 30 kg/m2)
Arms & Interventions
Free-hand lumbar punction
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.
Intervention: Free-hand therapeutic CT-guided punction for lumbar pain (Device)
Puncture Cube
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
Intervention: Puncture Cube (Device)
Outcomes
Primary Outcomes
Puncture accuracy
Time Frame: during procedure time approximately 30 min.
Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
Secondary Outcomes
- Number of control acquisitions to achieve target(during procedure time approximately 30 min.)
- Assessment of radiation dose(during procedure time approximately 30 min.)
- Assessment of intervention time(during procedure time approximately 30 min.)
Investigators
Luca Remonda
Prof. Dr. med.
Kantonsspital Aarau