US-based medical device and tissue processing firm CryoLife has started patient enrolment in its PerClot investigational device exemption (IDE) clinical trial.
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Data from the trial will help the company secure approval to commercialise PerClot in the US.
A total of 324 patients across cardiac, general and urological surgical specialties will be included in the multi-centre, multidisciplinary, controlled clinical investigation PerClot IDE trial.
The trial’s primary objective will be to collect clinical data concerning the safety and efficacy of PerClot compared to CR Bard’s Arista MPH Hemostat in multiple surgical disciplines, when used as an adjunct to conventional means of achieving haemostasis such as pressure or ligature.
The primary efficacy endpoint of the trial will be achievement of haemostasis at the site of application at seven minutes following application of the prescribed hemostatic agent. The secondary efficacy endpoint will be haemostasis at the site of application, evaluated at five minutes.
CryoLife president Pat Mackin said: "The first patient enrolled in the PerClot IDE clinical trial is a positive milestone for the company and our strategy to expand indications for our products.
"We will be working to bring other trial sites online in the coming months, positioning us to complete enrolment in the trial in the first half of 2016.
"With a three-month follow-up period, we would anticipate obtaining FDA approval for PerClot in the second half of 2017."
PerClot is composed of delivery applicators and polysaccharide granules, which are biocompatible, non-pyrogenic and derived from purified plant starch.
The trial’s safety endpoints will include, but are not limited to, the incidence of reoperation due to bleeding, total hospitalisation and procedure time, and the incidence of procedure complications and/or adverse events through final patient follow-up at three months.
