ZEST EU

• Research type

  Research Study

• Full title

  The Zenflow Spring System EU Safety and Performance Study

• IRAS ID

  248567

• Contact name

  Nikesh Thiruchelvam

• Contact email

  nikesh.thiruchelvam@addenbrookes.nhs.uk

• Sponsor organisation

  Zenflow Inc

• Clinicaltrials.gov Identifier

  NCT03577236

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  The Zenflow Spring System EU Safety and Performance Study (ZEST EU).

  The study aims to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

  The Zenflow Spring System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men aged 45 and above.

  The Zenflow Spring System consists of a single-use scope, delivery system, a self-expanding Spring Implant, and accessories.

  Up to 50 patients will be implanted with the device. It is expected that several NHS hospitals will participate in the study. Following implantation, participants will be followed for up to 24 months and will undergo a variety of standard tests and urology assessments designed to assess the safety and performance of the device.

• REC name

  West of Scotland REC 4

• REC reference

  18/WS/0157

• Date of REC Opinion

  17 Oct 2018

• REC opinion

  Further Information Favourable Opinion