ImageIQ selected as imaging CRO for CryoLife’s PerClot Intraoperative Hemostasis pivotal clinical trial

Share
CryoLife

ImageIQ announced that it has been chosen by CryoLife to provide its complement of clinical trial management and imaging support services and technology.

ImageIQ, an innovative imaging software and Contract Research Organization (CRO) focused on supporting preclinical research and clinical trials, announced that it has been chosen by CryoLife to provide its full complement of clinical trial management and imaging support services and technology for a new prospective multi-center pivotal clinical trial seeking to generate safety and efficacy data for medical device IDE approval.

ImageIQ’s technology and services will be used in support of CryoLife’s IDE study of their PerClot Polysaccharide 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.

Specifically, CryoLife will leverage ImageIQ’s EDCIQ imaging-enabled electronic data capture (EDC) system, customized specifically to the study’s design and workflow to support compliance with all imaging-related activities.

Additionally, ImageIQ will develop and validate the imaging and image analysis protocols, procure, test and install imaging hardware, provide study site imaging qualification, training and management, and provide quantitative software-based image QA and processing prior to expert image evaluation by centralized surgical readers. Lastly, ImageIQ will also support all imaging-related data collection, transfer, storage and management.

ImageIQ
image-iq.com

DeviceTalks West: Expertise you need to know

textadimage Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm.

From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in their own right.

Read on to discover five example of medical device expertise to be had at DeviceTalks West, which runs Dec. 11–12 in Orange County, Calif.

Speak Your Mind

*