Ann: CE Mark Update, page-154

The clinical investigation will be conducted at approximately 5 sites in the United States involving 20 patients.

	ActualEnrollment:	9 participants

https://clinicaltrials.gov/ct2/show/NCT03076216

Onpac-1 U.S and International Clinical StudyAs previously advised, the company had filed an IDE Amendment with the FDA for its planned global clinical study of OncoSil™ for the treatment of pancreatic cancer (OncoPac-1).This followed an intensive eight month process of submissions and interactions with the FDA.The company has received notification from the FDA that the IDE Amendment submission has been approved thereby clearing the way for the company to initiate its planned global clinical study, OncoPac-1.The key details of OncoPac-1 study are as follows:- OncoPac-1 is a global, multi-centre, randomised, open label, pivotal efficacy and safety study of OncoSil™. The Study is intended to include up to 30 centres in the United States and other international markets including the United Kingdom, Europe and Australia;- In this pivotal study, a total of 300 subjects will be recruited with locally advanced unresectable adenocarcinoma of the pancreas. Stage 1 of the Study consists of 20 subjects across a maximum of 5 centres in the United States

https
://www.google.com/amp/s/www.*.com.au/companies/amp/news/160327://clinicaltrials.gov/ct2/show/NCT03076216