NCT04809298

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

Prospective, Randomized, Controlled, Parallel Group Study to Compare a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Luca Remonda · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lumbar Pain

Interventions

Type	Name	Description
DEVICE	Free-hand therapeutic CT-guided punction for lumbar pain	Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
DEVICE	Puncture Cube	Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.

Timeline

• Start date: 2019-06-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-03-22
• Last updated: 2022-04-07

Locations

1 site across 1 country: Switzerland