Recruiting

Zenflow Spring System

Sponsor:

Zenflow, Inc.

Code:

NCT07538622

Conditions

BPH (Benign Prostatic Hyperplasia)

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zenflow Spring System

Study Details

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.

Conditions

BPH (Benign Prostatic Hyperplasia)

Study ID

NCT07538622

Start date

Jul 29, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

Zenflow Spring System

Minimally Invasive Treatment for LUTS associated with BPH

Primary outcome measure

  • Effectiveness - IPSS [ Time Frame: Baseline to 12 Months ]
  • Safety - adverse events [ Time Frame: Baseline to 12 Months ]

Central Contacts and Locations

Locations

San Diego Clinical Trials

Recruiting

La Mesa, California, United States, 91942

Contacts

Study Coordinator

619-287-6000brianhamblen@sdclinicaltrials.com

Principal Investigator:

Mohamed Bidair, MD

Gulf Coast Clinical Trial Associates / Florida Urology Partners

Recruiting

Tampa, Florida, United States, 33615

Contacts

Study Coordinator

(813) 875-8567jodi@gulfcoastcta.com

Study Coordinator

alex@gulfcoastcta.com

Principal Investigator:

Osvaldo Padron, MD

Avant Concierge Urology

Recruiting

Winter Garden, Florida, United States, 34787

Contacts

Sijo Parekattil, MD

407-547-1654sijo@avantconciergeurol.com

Study Coordinator

alana@avantconciergeurol.com

Principal Investigator:

Sijo Parekattil, MD

The Smith Institute of Urology/Northwell Health

Recruiting

Syosset, New York, United States, 11791

Contacts

Jennifer Polo, Study Coordinator

(516) 628-5910jpolo1@northwell.edu

Principal Investigator:

Bilal Chughtai, MD

Midtown Urology Associates

Recruiting

Austin, Texas, United States, 78705

Contacts

Study Coordinator

512-451-7935APBarger@cimplify.net

Principal Investigator:

Tyler McClintock, MD

More Information

Sponsor

Zenflow, Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Benign Prostatic Hyperplasia (BPH)
  • Symptomatic BPH
  • BPH
  • Benign Prostatic Hyperplasia
  • enlarged prostate
  • lower urinary tract symptoms (LUTS)
  • LUTS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zenflow, Inc. on 2026-09-01.