Clinical trial NCT04809298: Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method
Official title: Prospective, Randomized, Controlled, Parallel Group Study to Compare a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Pain
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, parallel group study
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Puncture accuracy
timeFrame: during procedure time approximately 30 min.
Secondary outcomes:
measure: Number of control acquisitions to achieve target
timeFrame: during procedure time approximately 30 min.
measure: Assessment of radiation dose
timeFrame: during procedure time approximately 30 min.
measure: Assessment of intervention time
timeFrame: during procedure time approximately 30 min.
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Department of Neuroradiology, Kantonsspital Aarau
state: Aargau
Study officials:
affiliation: Department of Neuroradiology, Kantonsspital Aarau
name: Luca Remonda, Prof.
role: PRINCIPAL_INVESTIGATOR
References: