Identification of Spine Structures by Using BIP-Needles

Injeq

Status: Completed

Conditions: Spinal Puncture

Treatments: Device: Injeq Bioimpedance Probe (BIP) Needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02602912

INJ-SPINE-01

Details and patient eligibility

About

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

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Injeq Bioimpedance Probe (BIP) Needle

Experimental group

Description:

Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability.

Treatment:

Device: Injeq Bioimpedance Probe (BIP) Needle