An interventional study of Free-hand therapeutic CT-guided punction for lumbar pain and Puncture Cube in Lumbar Pain, sponsored by Luca Remonda. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Luca Remonda · Not applicable, Interventional, and Treatment
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).
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).
2,817 studies on the registry are indexed under Low Back Pain; 481 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →This is the only study on the registry with Luca Remonda as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Puncture Cube
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.
Puncture accuracy
Assessment of puncture accuracy (distance and angle error between planned and achieved trajectory)
Time frame: during procedure time approximately 30 min.
Number of control acquisitions to achieve target
Number of control acquisitions to achieve target
Time frame: during procedure time approximately 30 min.
Assessment of radiation dose
Assessment of radiation dose
Time frame: during procedure time approximately 30 min.
Assessment of intervention time
Assessment of intervention time
Time frame: during procedure time approximately 30 min.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.