OPEN study, Revision B, Amendment 03

• Research type

  Research Study

• Full title

  Optiflow PatEncy and MaturatioN Clinical Trial

• IRAS ID

  159031

• Contact name

  Eric Chemla

• Contact email

  eric.chemla@stgeorges.nhs.uk

• Sponsor organisation

  Bioconnect Systems Inc

• Clinicaltrials.gov Identifier

  NCT01921933

• Research summary

  This is a multi-centre, prospective, single arm, clinical study. The study is being conducted in more than one hospital or setting and the patient will receive the medical device. The objective of this study is to assess the performance and safety of the Optiflow Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous arteriovenous fistula (AVF) anastomoses.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  14/EE/1051

• Date of REC Opinion

  29 Aug 2014

• REC opinion

  Further Information Favourable Opinion