Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757116
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2021-02-07
Brief Title:
Post-Market Study to Assess iTind Safety in Comparison to UroLift
Sponsor:
Olympus Corporation of the Americas
Organization:
Olympus Corporation of the Americas
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MT-08
Brief Summary:
The study objective is to evaluate the safety of the iTind device comparied to UroLift
Detailed Description:
UroLift is a treatment for relieving lower urinary tract symptoms LUTS secondary to benign Prostatic Hyperplasia BPH as a minimally invasive procedure This procedure has proven to have high efficacy with regards to improving objective and subjective parameters The iTind is a minimally invasive temporary device designed to relieve LUTS secondary to BPH This study is designed to compare the minimally invasive iTind device to UroLift
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None