Identification of Spine Structures by Using BIP-Needles

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02602912
• Date of registration: 09/11/2015
• Prospective Registration: No
• Primary sponsor: Injeq Ltd
• Public title: Identification of Spine Structures by Using BIP-Needles
• Scientific title: INJ-SPINE-01 Identification of Spine Structures by Using BIP-Needles
• Date of first enrolment: May 2015
• Target sample size: 69
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02602912
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Finland

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Puncture

Intervention(s)

Device: Injeq Bioimpedance Probe (BIP) Needle

Primary Outcome(s)

True positive and false positive detection of cerebrospinal fluid marked in case report form [Time Frame: During spinal puncture]

Secondary ID(s)

INJ-SPINE-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors