Spinal Puncture
Conditions
Brief summary
The main purpose of the study is to assess the feasibility and clinical performance of impedance based tissue identification in various spine structures.
Interventions
Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.
Sponsors
Injeq Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Voluntary adult patients going through medical operation involving spinal puncture, spinal fluid sampling or intrathecal drug injection.
Exclusion criteria
* Participation to other clinical study *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True positive and false positive detection of cerebrospinal fluid marked in case report form | During spinal puncture | Measurement device indicates with a sound and visual feedback when needle reaches cerebrospinal fluid (CSF). Physician verifies the location by removing the needle stylet and testing whether CSF flows from the needle, similarly as in traditional process. Detection is true positive if CSF flows from the needle and false positive if not. Even if the device does not detect the spinal fluid, physician performs the CSF test when needed. Physician marks to the case report form whether the device provided detections during the spinal puncture and were the detections true or false detections. |
Countries
Finland
Outcome results
None listed