ImageIQ will provide full complement of clinical trial management and imaging support services and technology for the trial, which seeks to generate safety and efficacy data for medical device IDE approval.
The multi-center pivotal clinical trial will assess the safety and efficacy of PerClot ploysaccharide hemostatic system in patients in need of adjunctive intraoperative hemostasis during open elective cardiac, general or urological surgery when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
The EDC imaging-enabled electronic data capture (EDC) system of ImageIQ has been customized specifically to the study’s design and workflow to support compliance with all imaging-related activities.
ImageIQ will also develop and validate the imaging and image analysis protocols, procure, test and install imaging hardware required for the study.
It will also offer study site imaging qualification, training and management, in addition to quantitative software-based image QA and processing prior to expert image evaluation by centralized surgical readers.
In addition, the company will provide all imaging-related data collection, transfer, storage and management services.
ImageIQ is an imaging contract research organization (ICRO), which offers image management software, image analysis capabilities, protocol development, biomarker exploration, and clinical trial management expertise for imaging in drug and medical device clinical trials.
Based in Atlanta of Georgia, CryoLife is engaged in the manufacturing, processing, and distribution of medical devices and implantable living tissues used in cardiac surgical procedures.
