Signia

• Research type

  Research Study

• Full title

  A prospective, two-arm, multicenter, post market study to confirm the safety and performance of the Signia™ Stapling System using Endo GIA™ Reloads with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in abdominal and thoracic procedures.

• IRAS ID

  256094

• Contact name

  Manoj Purohit

• Contact email

  Mr.Purohit@bfwhospitals.nhs.uk

• Sponsor organisation

  Medtronic

• Clinicaltrials.gov Identifier

  NCT03515811

• Duration of Study in the UK

  1 years, 3 months, 22 days

• Research summary

  This study will recruit patients who are to undergo thoracic or abdominal surgery, using procedures such as resection, transection and creation of anastomosis per the IFU. An anastomosis is a connection made between two adjacent blood vessels either naturally or surgically.
  The purpose of this study is to confirm safety and performance through the incidence of reported adverse device effects (ADEs) up to and including 30 days following the use of SigniaTM Stapling System which is approved by the authorities for use by doctors in the management of patients who have to undergo an indicated primary abdominal or thoracic procedure. It is routinely available as part of normal clinical care and is not experimental

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  19/YH/0064

• Date of REC Opinion

  5 Apr 2019

• REC opinion

  Further Information Favourable Opinion