Identification of Spine Structures by Using BIP-Needles

Spinal Puncture Clinical Trial

Official title:

INJ-SPINE-01 Identification of Spine Structures by Using BIP-Needles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602912
• Other study ID #: INJ-SPINE-01
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 2018

Study information

• Verified date: February 2019
• Source: Injeq Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of the study is to assess the feasibility and clinical performance of impedance based tissue identification in various spine structures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Exclusion criteria are the same as generally for spinal anaesthesia and lumbar punctures. Exclusion criteria includes infection on skin area, systemic anticoagulation, sepsis, anatomical unsuitability and refusal

• In addition for not giving (or not capable to give) the consent personally for any reason is an absolute exclusion criterion. In practice this means that study is for adult patients only.

Related Conditions & MeSH terms

• Spinal Puncture

Intervention

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.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Injeq Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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