Viz.ai and NICO have announced a collaboration to incorporate a new innovative clinical trial recruitment software from Viz.ai into the seminal ENRICH study which is investigating the treatment of intracerebral haemorrhages.
The current standard of care for intracerebral haemorrhages calls for medical management of the patient, or a “watch and see” protocol, which allows blood that is pooled from the ruptured vessel to remain in the brain. The ENRICH trial is evaluating the efficacy and safety of early surgical evacuation (less than 24 hours) using a parafascicular (parallel to the brain’s fibre tracts) and trans-sulcal (through natural openings and folds of the brain) surgical approach. The goal of surgical evacuation is to maximise clot removal, achieve durable haemostasis, and achieve functional improvement of the patient.
Viz RECRUIT utilises advanced artificial intelligence to automatically identify potential subjects for clinical trials. In ENRICH (Early Minimally-invasive removal of intracerebral haemorrhages), Viz RECRUIT will notify investigators immediately when a patient meets the eligibility criteria for enrolment. Study investigators can coordinate subject enrolment easily and securely through a dynamic, mobile, HIPAA-compliant platform.
“Automated detection and notification of suspected ICH patients using artificial intelligence has the potential to significantly speed ENRICH trial enrolment,” said Gustavo Pradilla, assistant professor of neurosurgery at Emory University and chief of neurosurgery at Grady Memorial Hospital. “Viz’s AI technology allows investigators to identify more trial eligible candidates and therefore potentially shorten clinical trials.”
“With the added value that Viz.ai is bringing to ENRICH with its imaging and workflow software, the trial can potentially be shortened through faster enrolment and provide a reduced time to randomisation,” said Jim Pearson, president and CEO of NICO. “All this translates into being able to more quickly offer patients validated clinical trial outcomes as we work toward new intracerebral haemorrhages treatment protocols for this most deadly and debilitating form of stroke.”
ENRICH is a multicentre trial sponsored by NICO and led by the Emory Stroke Center of Emory University hospitals and the Marcus Stroke & Neuroscience Center of Grady Memorial Hospital, both in Atlanta. Ideal trial subjects are spontaneous supratentorial intracerebral haemorrhage patients with a potential chance of benefiting from surgical treatment based on well-defined criteria for study enrolment.
“The ENRICH trial and NICO technologies can potentially transform the way that ICH is treated and change treatment guidelines,” said Chris Mansi, neurosurgeon and CEO of Viz.ai.
ENRICH opened patient enrolment in January 2017 for the 300-patient trial that includes multidisciplinary teams of stroke neurology, neurosurgery and neuro-critical care physicians from 30 trial sites that include major medical and academic centres and large community hospitals.