A randomized study to assess the safety of iTind vs. Urolift

• Research type

  Research Study

• Full title

  A Post-Market, Prospective, Randomized, Controlled, Multicenter International Study to Assess the Safety of the Temporarily Implanted Nitinol Device (iTind) Compared to the UroLift® System in Subjects with Symptomatic Benign Prostatic Hyperplasia (BPH)

• IRAS ID

  316330

• Contact name

  Neil Barber

• Contact email

  neil.barber@nhs.net

• Sponsor organisation

  Olympus Europa SE & Co. KG

• Clinicaltrials.gov Identifier

  NCT04757116

• Duration of Study in the UK

  3 years, 0 months, 29 days

• Research summary

  This is a post-market prospective, multi-center, 1:1 randomized study that will assess the safety of the iTind, a minimally invasive medical device, compared to a another minimally invasive system Urolift in the treatment of lower urinary tract symptoms (LUTS) secondary to Benign Prostate Hyperplasia (BPH).
  Eligible subjects will be randomized 1:1 to iTind or UroLift and have the procedure scheduled for the implantation of iTind or Urolift. Subjects in iTind arm will have the device removed after 5-7 days whereas, Urolift is a permanent impant that remains in the prostatic urethra. Subjects will have follow-up visits at two weeks, 1, 3, 6, 12, 18, and 24 months after the implantation.

  The study is intended to be conducted at 15 different centers in the United Kingdom, the United States and Canada to enroll up to 250 subjects.
  

• REC name

  West of Scotland REC 4

• REC reference

  22/WS/0161

• Date of REC Opinion

  19 Dec 2022

• REC opinion

  Further Information Favourable Opinion