Health Canada has granted investigational testing approval (ITA) to CellAegis Devices to initiate a pilot clinical trial of its noninvasive autoRIC device for remote ischemic conditioning (RIC).
Placed around the arm, the CE-marked device is designed to automate RIC at the point of care including acute care applications in the ambulance, emergency room and other hospital settings, or for treatment in the home as directed by a healthcare professional.
The study, which will enroll 24 adult patients with stage T1 renal cell carcinoma, is designed to demonstrate the device’s ability in reducing acute kidney injury induced by intraoperative renal ischemia during partial nephrectomy.
Patients will be randomised as a treatment group, to whom RIC will be initiated after anesthesia induction and prior to the surgical procedure, and a control group wearing a standard uninflated blood pressure cuff.
Postoperative measurements including serum creatinine, eGFR, and serum NGAL (a renal injury biomarker) will be measured in all patients at 2, 6, and 24 hours intervals.
CellAegis Devices CEO Rocky Ganske said in 2012, the company has seen both increasing physician awareness of the value of RIC and adoption of its technology in clinical programmes.
"The trial at Princess Margaret Hospital brings the autoRIC Device to a new set of clinicians and key opinion leaders, and extends our geographic reach following the initiation of clinical testing of RIC in the ongoing STEMI study in the EU," Ganske said.
"In addition to the ongoing studies, we anticipate seeking regulatory approval to begin our own clinical program in the US in the near term.
"Our primary focus remains in cardiovascular indications, and we believe RIC has the potential to provide benefit for patients across a wide range of indications in this arena."