Identification of Spine Structures by Using BIP-Needles
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02602912|
Recruitment Status : Active, not recruiting
First Posted : November 11, 2015
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Puncture||Device: Injeq Bioimpedance Probe (BIP) Needle||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||INJ-SPINE-01 Identification of Spine Structures by Using BIP-Needles|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Injeq Bioimpedance Probe (BIP) Needle
Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability.
Device: Injeq Bioimpedance Probe (BIP) Needle
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.
- True positive and false positive detection of cerebrospinal fluid marked in case report form [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602912
|Tampere University Hospital|
|Tampere, Finland, FI- 33521|