Identification of Spine Structures by Using BIP-Needles

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

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

Study Overview

• Status: Completed
• Conditions: Spinal Puncture
• Intervention / Treatment: Device: Injeq Bioimpedance Probe (BIP) Needle

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, FI- 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Injeq Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: INJ-SPINE-01