Identification of Spine Structures by Using BIP-Needles
INJ-SPINE-01 Identification of Spine Structures by Using BIP-Needles
1 other identifier
interventional
69
1 country
1
Brief Summary
The main purpose of the study is to assess the feasibility and clinical performance of impedance based tissue identification in various spine structures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedFebruary 27, 2019
February 1, 2019
3.5 years
November 9, 2015
February 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Injeq Bioimpedance Probe (BIP) Needle
EXPERIMENTALInjeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability.
Interventions
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 Criteria
You may qualify if:
- Voluntary adult patients going through medical operation involving spinal puncture, spinal fluid sampling or intrathecal drug injection.
You may not qualify if:
- Participation to other clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Injeq Ltdlead
Study Sites (1)
Tampere University Hospital
Tampere, FI- 33521, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
November 11, 2015
Study Start
May 1, 2015
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
February 27, 2019
Record last verified: 2019-02