Laminate External Support Protocol, Rev 01

• Research type

  Research Study

• Full title

  A prospective, multi center, study to evaluate the safety and efficacy of the Laminate external support device for brachiocephalic arteriovenous fistula

• IRAS ID

  148199

• Contact name

  Eric Chemla

• Contact email

  eric.chemla@stgeorges.nhs.uk

• Sponsor organisation

  Laminate Ltd.

• Research summary

  The study is a prospective, multi center, study and is designed to demonstrate safety and effectiveness of the medical device. Up to 20 patients will be enrolled. Patients will be followed for 6 months with follow up visits scheduled at 1, 3, and 6 months.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  14/EE/0062

• Date of REC Opinion

  17 Mar 2014

• REC opinion

  Further Information Favourable Opinion