CLEAR
Research type
Research Study
Full title
Comparing UroLift System Experience Against Rezum
IRAS ID
282988
Contact name
Bryan Arebalo
Contact email
Sponsor organisation
NeoTract, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
This is a prospective, multicenter, two-arm, 1:1 randomized study comparing safety and efficacy (through patient reported outcomes) in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH) that are treated with either the UroLift® System or Rezūm™ System. Approximately 120 subjects will be randomized (1:1) and enrolled at a minimum of 10 sites across US and UK centers. This is the first BPH study comparing patient reported outcomes between the UroLift® System and Rezūm™ System by evaluating results pertaining to study design, endpoint, conduct of trial, site performance, subject compliance, and inclusion criteria specifically, a robust safety and effectiveness study can follow. Clinical improvements will be assessed post-procedure at Day 3, Day 3 catheter removal (if required), Day 7, 2 weeks, and at months 1, 3, and 12 post-index procedure.
REC name
HSC REC B
REC reference
20/NI/0172
Date of REC Opinion
22 Jan 2021
REC opinion
Further Information Favourable Opinion