Finland-based firm Injeq has announced the expansion of clinical trials of its IQ-Needle to University Children’s Hospitals in Denmark, Norway and Sweden, following a successful crowdfunding in Europe.
The tissue-identifying Injeq IQ-Needle features a unique electrode and the firm’s BZ-301 analyser for advanced real-time information.
The electrode enables bioimpedance measurement of the tissue that is in contact with the needle’s tip, while the low energy measurement signal allows the analyser to identify changes due to tissue contact, and calculate the impedance in different frequency points.
Designed for clinical applications such as regional anaesthesia, lumbar punctures, biopsy, and intra-tumoural drug delivery, the device is expected to improve diagnosis, minimise complications, and facilitate new treatments for patients.
Being tested for use in paediatric acute lymphatic leukaemia (ALL) patients who receive traumatic lumbar punctures, the needle is expected to improve the success rate, as well as minimise trauma and bleeding in newborns and children due to the punctures.
The characteristic of the needle to alert the physician upon contact with the target spinal fluid allows prevention of complications associated with excessive needle penetration.
Injeq Clinical Development and Sales vice-president Dr Rami Lehtinen said: “International studies are an important step in demonstrating the benefits of Injeq IQ-Needle. Preparations and planning for new studies have now been started.”
The Karolinska University Hospital at Stockholm, Sweden, is also set to initiate a clinical trial of the needle in premature infants who are prescribed to receive a lumbar puncture.
The results from previous clinical trials conducted in Finland are reported to be encouraging.