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Identification of Spine Structures by Using BIP-Needles

This study is currently recruiting participants.
Verified June 2017 by Injeq Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT02602912
First Posted: November 11, 2015
Last Update Posted: June 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Injeq Ltd
  Purpose
The main purpose of the study is to assess the feasibility and clinical performance of impedance based tissue identification in various spine structures.

Condition Intervention
Spinal Puncture Device: Injeq Bioimpedance Probe (BIP) Needle

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: INJ-SPINE-01 Identification of Spine Structures by Using BIP-Needles

Further study details as provided by Injeq Ltd:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: May 2015
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Arvi Yli-Hankala, Prof. MD arvi.yli-hankala@pshp.fi

Locations
Finland
Tampere University Hospital Recruiting
Tampere, Finland, FI- 33521
Contact: Arvi Yli-Hankala, Prof. MD       arvi.yli-hankala@pshp.fi   
Sponsors and Collaborators
Injeq Ltd
  More Information

Responsible Party: Injeq Ltd
ClinicalTrials.gov Identifier: NCT02602912     History of Changes
Other Study ID Numbers: INJ-SPINE-01
First Submitted: November 9, 2015
First Posted: November 11, 2015
Last Update Posted: June 7, 2017
Last Verified: June 2017