Back to resultsComparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method (PunctureCube)
Primary Purpose
Lumbar Pain
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Free-hand therapeutic CT-guided punction for lumbar pain
Puncture Cube
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Pain
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)
Sites / Locations
- Department of Neuroradiology, Kantonsspital AarauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Free-hand lumbar punction
Puncture Cube
Arm Description
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
Outcomes
Primary Outcome Measures
Puncture accuracy
Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
Secondary Outcome Measures
Number of control acquisitions to achieve target
Number of control acquisitions to achieve target
Assessment of radiation dose
Assessment of radiation dose
Assessment of intervention time
Assessment of intervention time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04809298
Brief Title
Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luca Remonda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled, parallel group study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Free-hand lumbar punction
Arm Type
Other
Arm Description
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.
Arm Title
Puncture Cube
Arm Type
Active Comparator
Arm Description
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
Intervention Type
Device
Intervention Name(s)
Free-hand therapeutic CT-guided punction for lumbar pain
Intervention Description
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
Intervention Type
Device
Intervention Name(s)
Puncture Cube
Intervention Description
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
Primary Outcome Measure Information:
Title
Puncture accuracy
Description
Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
Time Frame
during procedure time approximately 30 min.
Secondary Outcome Measure Information:
Title
Number of control acquisitions to achieve target
Description
Number of control acquisitions to achieve target
Time Frame
during procedure time approximately 30 min.
Title
Assessment of radiation dose
Description
Assessment of radiation dose
Time Frame
during procedure time approximately 30 min.
Title
Assessment of intervention time
Description
Assessment of intervention time
Time Frame
during procedure time approximately 30 min.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Remonda, Prof.
Phone
+41 62 838 43 21
Email
luca.remonda@ksa.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Remonda, Prof.
Organizational Affiliation
Department of Neuroradiology, Kantonsspital Aarau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neuroradiology, Kantonsspital Aarau
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Remonda, Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of a New Needle Navigation Device for CT-guided Interventions to the Conventional Free-hand Method
We'll reach out to this number within 24 hrs