Clinical Evaluation of the FlexDex Surgical Instrument in Thoracics.

• Research type

  Research Study

• Full title

  A Clinical Evaluation of the FlexDex Surgical Instrument in Thoracic Surgery

• IRAS ID

  225207

• Contact name

  Joel Dunning

• Contact email

  joeldunning@nhs.net

• Sponsor organisation

  South Tees Hospitals NHS Foundation Trust

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  FlexDex surgical instruments have designed in the USA a series of instruments that may be beneficial for use in keyhole surgery. Usually when performing keyhole surgery, stitching is very difficult but for the first time, a keyhole instrument has been created that can stitch very easily.
  Already used clinically in the USA, we would like to be the first site in Europe to test its safety and effectiveness in lung surgery. We would like to test it in 3 operative situations, in keyhole surgery of the chest for Diaphragm surgery, in keyhole lung cancer surgery and in keyhole thymectomy (An organ in the front of the chest) . We are unique in the UK in that we perform all 3 of these operations both by keyhole and Robotically and therefore are ideally placed to assess whether the flexdex surgical instrument will mean that the keyhole technique will become identical to the robotic technique in terms of its speed, safety and ease of performance. If we can demonstrate the effectiveness and safety of this new device there may be potential cost savings to the NHS as this will be a cheaper option than more expensive robotic surgery

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  17/NE/0338

• Date of REC Opinion

  1 Dec 2017

• REC opinion

  Further Information Favourable Opinion