Trials / Completed
CompletedNCT02792660
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Injeq Ltd · Industry
- Sex
- All
- Age
- 18 Months
- Healthy volunteers
- Not accepted
Summary
This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar puncture on paediatric patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Injeq IQ-Needle | Injeq IQ-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. |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2018-06-01
- Completion
- 2018-11-01
- First posted
- 2016-06-07
- Last updated
- 2018-11-21
Locations
2 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT02792660. Inclusion in this directory is not an endorsement.