Trials / Completed
CompletedNCT04271020
Urodynamic Feasibility Study Utilizing the UroLift® System
Urodynamic Feasibility Study (UDS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- NeoTract, Inc. · Industry
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- Accepted
Summary
UDS evaluates the impact of Prostatic Urethral Lift (PUL) as measured by pressure flow, urodynamic testing (UDS) and an optional UroCuff Testing, an alternative urodynamic test. In addition, standard BPH measures such as symptoms, qualify of life, uroflowmetry, and post void residual will be evaluated at screening and at the follow-up visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | UroLift | The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra. |
Timeline
- Start date
- 2018-10-25
- Primary completion
- 2019-04-22
- Completion
- 2019-11-27
- First posted
- 2020-02-17
- Last updated
- 2020-06-11
- Results posted
- 2020-05-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04271020. Inclusion in this directory is not an endorsement.