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
1 other identifier
interventional
120
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
March 5, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 7, 2022
April 1, 2022
3.6 years
March 5, 2021
April 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Puncture accuracy
Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
during procedure time approximately 30 min.
Secondary Outcomes (3)
Number of control acquisitions to achieve target
during procedure time approximately 30 min.
Assessment of radiation dose
during procedure time approximately 30 min.
Assessment of intervention time
during procedure time approximately 30 min.
Study Arms (2)
Free-hand lumbar punction
OTHERDiagnostic or therapeutic CT-guided intervention for lumbar pain management using the free-hand method.
Puncture Cube
ACTIVE COMPARATORDiagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
Interventions
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients suffering from severe obesity (BMI \> 30 kg/m2)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Luca Remondalead
Study Sites (1)
Department of Neuroradiology, Kantonsspital Aarau
Aarau, Canton of Aargau, 5001, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Remonda, Prof.
Department of Neuroradiology, Kantonsspital Aarau
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
March 5, 2021
First Posted
March 22, 2021
Study Start
June 1, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 7, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share