A randomized study to assess the safety of iTind vs. TURP in subjects
Research type
Research Study
Full title
A post market prospective, randomized, controlled, multi-center international study to assess the safety of the temporarily implanted nitinol device (iTind) compared to Transurethral Resection of the Prostate (TURP) in subjects with symptomatic Benign Prostatic Hyperplasia (BPH).
IRAS ID
297523
Contact name
Neil Barber
Contact email
Sponsor organisation
Medi-Tate
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The study will assess the safety of the iTind, a minimally invasive medical device, compared to a surgery which resects the prostate (TURP) and is considered as a gold standard procedure for Benign Prostate Hyperplasia (BPH). \nAfter assessing if the subject can participate in the study, he will be randomized into one of the following groups: the “iTind group” or the “TURP group” which means that the subject is put into a group by chance using a computer program. It is like flipping a coin - neither the subject nor the study doctor can choose the group. The subject will be allocated to his chosen group and be scheduled for a procedure. \nThe study is intended to be conducted at up to 12 different centers in Europe, United States and Canada to enroll up to 140 subjects.\nSubjects’ follow-up visits will be at 2 weeks, 1, 3, 6, and 12 months with an option to extend to 24 months and will include completing questionnaires, blood and urine tests and prostate measurements by ultrasound.\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0115
Date of REC Opinion
19 May 2021
REC opinion
Further Information Favourable Opinion