BPH (Benign Prostatic Hyperplasia)
Conditions
Keywords
Benign Prostatic Hyperplasia (BPH), Symptomatic BPH, BPH, Benign Prostatic Hyperplasia, enlarged prostate, lower urinary tract symptoms (LUTS), LUTS
Brief summary
The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.
Interventions
DEVICEZenflow Spring System
Minimally Invasive Treatment for LUTS associated with BPH
Sponsors
Zenflow, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Exclusion criteria
* Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness - IPSS | Baseline to 12 Months | The primary effectiveness endpoint is the change in IPSS from baseline over time |
| Safety - adverse events | Baseline to 12 Months | The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs) |
Countries
United States
Outcome results
None listed