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The main purpose of the study is to assess the feasibility and clinical performance of impedance based tissue identification in various spine structures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injeq Bioimpedance Probe (BIP) Needle | Experimental | Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injeq Bioimpedance Probe (BIP) Needle | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| True positive and false positive detection of cerebrospinal fluid marked in case report form | 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. | During spinal puncture |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | FI- 33521 | Finland |
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| ID | Term |
|---|---|
| D009339 | Needles |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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