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

Lumbar Pain Clinical Trial

— PunctureCube  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04809298
• Other study ID #: Puncture Cube
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Kantonsspital Aarau
• Contact: Luca Remonda, Prof.
• Phone: +41 62 838 43 21
• Email: luca.remonda[@]ksa.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Low Back Pain
• Lumbar Pain

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Neuroradiology, Kantonsspital Aarau	Aarau	Aargau

Sponsors (1)

Lead Sponsor	Collaborator
Luca Remonda

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Puncture accuracy	Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)	during procedure time approximately 30 min.
Secondary	Number of control acquisitions to achieve target	Number of control acquisitions to achieve target	during procedure time approximately 30 min.
Secondary	Assessment of radiation dose	Assessment of radiation dose	during procedure time approximately 30 min.
Secondary	Assessment of intervention time	Assessment of intervention time	during procedure time approximately 30 min.