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

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

• Status: Recruiting
• Conditions: Lumbar Pain
• Intervention / Treatment: Device: Free-hand therapeutic CT-guided punction for lumbar pain; Device: Puncture Cube

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Remonda, Prof.; Phone Number: +41 62 838 43 21; Email: luca.remonda@ksa.ch

Study Locations

• Switzerland
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Recruiting
      • Department of Neuroradiology, Kantonsspital Aarau
      • Contact: Luca Remonda, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Free-hand lumbar punction; Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.	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.
Active Comparator: Puncture Cube; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture accuracy	Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)	during procedure time approximately 30 min.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of control acquisitions to achieve target	Number of control acquisitions to achieve target	during procedure time approximately 30 min.
Assessment of radiation dose	Assessment of radiation dose	during procedure time approximately 30 min.
Assessment of intervention time	Assessment of intervention time	during procedure time approximately 30 min.

Collaborators and Investigators

• Sponsor: Luca Remonda
• Investigators: Principal Investigator: Luca Remonda, Prof., Department of Neuroradiology, Kantonsspital Aarau

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Puncture Cube

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No