IGAR Clinical Trials
CSii is currently conducting a multicentre, dual-arm, Phase II clinical trial for the Image Guided Automated Robot (IGAR) system. The first clinical application of IGAR is MRI-guided breast biopsies procedures. IGAR is fully MR compatible, which allows it to function within the bore of the scanner and register directly to a patient’s MR image set to ensure precision intervention.
A pilot Phase I clinical trial was completed in Quebec in March 2014 under the supervision of Dr. Nathalie Duchesne. Results from the pilot trial are extremely promising and demonstrate IGAR’s accuracy and usability. All IGAR biopsies were successful and no re-biopsies were required. Patients reported extremely low pain scores and excellent cosmetic outcome.
Following the success of Phase I, Health Canada approved a Phase II clinical trial, which was launched in December 2014. Phase II will involve two sites; Quebec City with Dr. Nathalie Duchesne and Hamilton with Dr. Colm Boylan. Up to 100 patients will enroll in the clinical trial. Phase II will be dual armed, and data will be collected from patients who undergo an IGAR breast biopsy and compared against the standard manual biopsy. We aim to comprehensively assess the benefits of IGAR technology so that we can continue to improve patient care.
In parallel, CSii is conducting preliminary research and phantom tests on other potential functionalities of the IGAR system. IGAR is designed to be a flexible robotic platform that can be adapted for a variety of clinical procedures including lung, liver, and kidney biopsy, and ablation. It can also integrate with other imaging modalities including ultrasound. IGAR can be teleoperated, allowing clinicians to control the robot at a distance thereby improving access to care in rural and remote regions.