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Dignitana AB announced that the company has submitted for review an application to the US Food and Drug Administration (FDA) Center for Devices and Radiologic Health for approval of the DigniCapTM System. The DigniCapTM System is currently approved for marketing in Australia, Canada, China, Colombia, most European countries, Mexico, Russian Federation, Singapore and South Korea.
Dignitana engaged the Clinical Research Organization (CRO) Target Health Inc., with offices in New York, in 2011, and Dignitana has been working in close collaboration with Target Health to interact with FDA, conduct the pivotal clinical trial and prepare the FDA application.
The pivotal clinical study was conducted at five clinical sites; University of California San Francisco, Wake Forest Baptist Medical Center, Weill Cornell Medical College, Beth Israel Medical Center, and UCLA Hematology Oncology Santa Monica. The first patient was enrolled in August, 2013 and the last patient was enrolled in October, 2014. A total of 101 evaluable patients were included in the treatment group and 16 patients were enrolled in the control group.
Dignitana would like to thank Target Health Inc., a Manhattan-based CRO, for their professionalism and expertise in interacting with the FDA, preparing and submitting the Investigational Device Exemption (IDE) and FDA application, as well as managing the clinical trial, performing data management, running the statistical analyses and writing the study report. Target Health’s novel approach to the paperless clinical trial included Target e*CTR (eClinical Trial Record®), a patented software that is fully integrated with Target e*CRF® (EDC). Use of this software resulted in an efficient and cost-effective clinical trial program, and allowed the clinical sites to enter the trial data directly into the study database at the time of the office visit.
Jan Richardson, Dignitana CEO, stated: ”The clinical trial was completed four months earlier than originally planned, thanks to the efforts of the investigators and their staff, and to the use of Target Health’s software solution for accelerating conduct of clinical trials.”
Glen Park, PharmD, Senior Director of Clinical and Regulatory Affairs at Target Health, commented on the submission, ”We appreciate the opportunity we have had to support Dignitana in bringing this important medical device to this stage of development and look forward to further interactions with FDA to obtain approval and bring the DigniCapTM System to market in the US.”