Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2026-03-11 @ 4:02 PM
Study NCT ID:
NCT01876706
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2013-05-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Sponsor:
NeoTract, Inc.
Organization:
Study Overview
Official Title:
L.O.C.A.L. Study -- UroLift System TOlerability and ReCovery When Administering Local Anesthesia
Status:
COMPLETED
Status Verified Date:
2019-03
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:
LOCAL
Brief Summary:
The purpose of the study is to evaluate procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia in subjects with symptomatic benign hyperplasia (BPH). Primary effectiveness will be achieved by looking at the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit.
Detailed Description:
The randomized portion of the study is a prospective, multicenter, non-blinded, single arm trial evaluating procedure tolerability and surgical recovery following the UroLift® system procedure when conducted with local anesthesia. All subjects undergo UroLift system treatment and will be followed through 5 years after receiving the investigational device.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: