With the invaluable collaboration with the physicians and nurses in our partner university hospitals, Injeq’s recent clinical investigation was successfully completed in short order.
Regulation on medical devices (MDR) emphasizes the importance of clinical evaluation in demonstrating the performance, benefits and acceptability of risks of all medical devices. Our pivotal investigation with Injeq IQ-Tip® system was designed to complement the two previous feasibility studies and to provide the final clinical evidence necessary for the clinical evaluation and market entry of our product.
Injeq was fortunate to have excellent collaboration partners and contacts from earlier studies with pediatric hemato-oncologic departments in Finnish University Hospitals. Initiating a new clinical investigation was therefore straightforward. This investigation was set to include more than 150 lumbar punctures to pediatric acute lymphoblastic leukemia (ALL) patients using Injeq IQ-Tip® system. The principal investigators and research nurses in Tampere, Helsinki and Turku University Hospitals were on board right from the early planning stages. They contributed essentially to the investigation protocol, plan and other important documents. Undoubtedly, this helped us to ensure that the patient enrolment and procedures began smoothly after all necessary approvals and permissions were obtained from ethics committee, national competent authority (Valvira) and hospital administrations.
The first patients were enrolled in November 2019. However, just few months after the start of investigation, Covid-19 pandemic abruptly kicked in and our investigation was affected as well. Enrolment of new participants was even briefly stopped as the hospital districts prioritized their operations and suspended all clinical investigations. Thankfully, part of these restrictions were lifted rather quickly. After all, the treatment of children with ALL follow their scheduled protocols regardless of global pandemic.
The last lumbar puncture of the investigation was done in August 2020 and the data collection phase was completed in early September 2020 ─ just 13 months after the ethics committee approval. Thereafter in October, all reports needed for regulatory purposes were written and submitted to the notified body for the currently ongoing conformity assessment. The scientific report of the investigation is under preparation and is expected to be published in an international peer-reviewed journal in 2021.
Ultimately, we wish to express our gratitude to principal investigators, physicians, research nurses and entire teams at the hospital sites for contributing to the successful completion of the investigation!
- Tampere University Hospital, Pediatric hematology and oncology & PeeTU (Pediatric Early Phase Trials Unit)
- Helsinki University Hospital, New Children’s Hospital, Pediatric hemato-oncology and stem cell transplantation.
- Turku University Hospital, Pediatric hematology and oncology