Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method (PunctureCube)

Luca Remonda

Status: Unknown

Conditions: Lumbar Pain

Treatments: Device: Puncture Cube; Device: Free-hand therapeutic CT-guided punction for lumbar pain

Study type: Interventional

Funder types: Other

Identifiers

NCT04809298

Puncture Cube

Details and patient eligibility

About

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).

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Free-hand lumbar punction

Other group

Description:

Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.

Treatment:

Device: Free-hand therapeutic CT-guided punction for lumbar pain

Puncture Cube

Active Comparator group

Description:

Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.

Treatment:

Device: Puncture Cube