Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts 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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective

Recruiting Locations

San Diego Clinical Trials
La Mesa, California 91942
Contact:
Study Coordinator
619-287-6000
brianhamblen@sdclinicaltrials.com

Gulf Coast Clinical Trial Associates / Florida Urology Partners
Tampa, Florida 33615
Contact:
Study Coordinator
(813) 875-8567
jodi@gulfcoastcta.com

Avant Concierge Urology
Winter Garden, Florida 34787
Contact:
Sijo Parekattil, MD
407-547-1654
sijo@avantconciergeurol.com

The Smith Institute of Urology/Northwell Health
Syosset, New York 11791
Contact:
Jennifer Polo, Study Coordinator
(516) 628-5910
jpolo1@northwell.edu

Midtown Urology Associates
Austin, Texas 78705
Contact:
Study Coordinator
512-451-7935
APBarger@cimplify.net

More Details

Status
Recruiting
Sponsor
Zenflow, Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.