Trials / Completed
CompletedNCT03194737
Prostatic Urethral Lift in Subject With Acute Urinary Retention
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- NeoTract, Inc. · Industry
- Sex
- Male
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).
Detailed description
The study is a multi-centre, prospective evaluation of PUL and retrospective review of invasive surgery as potential comparator. The study is intended to be conducted at up to 5 different centres in the United Kingdom to enrol up to 50 subjects. Subject follow-up visits are at post-procedure, 6 weeks, 3 months, 6 months and 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | UroLift System Procedure | Minimally invasive procedure in patients with acute urinary retention secondary to BPH. |
Timeline
- Start date
- 2018-03-24
- Primary completion
- 2019-01-21
- Completion
- 2020-03-03
- First posted
- 2017-06-21
- Last updated
- 2021-07-16
- Results posted
- 2021-07-16
Locations
6 sites across 1 country: United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03194737. Inclusion in this directory is not an endorsement.