BPH (Benign Prostatic Hyperplasia)NCT07538622
Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry
An observational study of BPH (Benign Prostatic Hyperplasia), run by Zenflow, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- Zenflow Spring System
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Jul 2026to Sep 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
Who may be able to join
- Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Who cannot join
- Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 6 recruiting
- Recruiting
Midtown Urology Associates
Austin, Texas, 78705
Study Coordinator, 512-451-7935, APBarger@cimplify.net
Tyler McClintock, MD
- Active, not recruiting
Dr Slade Urology
Boise, Idaho, 83704
- Recruiting
San Diego Clinical Trials
La Mesa, California, 91942
Study Coordinator, 619-287-6000, brianhamblen@sdclinicaltrials.com
Mohamed Bidair, MD
- Active, not recruiting
START Research
Myrtle Beach, South Carolina, 29572
- Not yet recruiting
Chopra Urology
Phoenix, Arizona, 85032
Study Coordinator, (602) 777-3113, Medical.Assistant@chopraurology.com
Sameer Chopra, MD
- Recruiting
The Smith Institute of Urology/Northwell Health
Syosset, New York, 11791
Jennifer Polo, Study Coordinator, (516) 628-5910, jpolo1@northwell.edu
Bilal Chughtai, MD
- Recruiting
Gulf Coast Clinical Trial Associates / Florida Urology Partners
Tampa, Florida, 33615
Study Coordinator, (813) 875-8567, jodi@gulfcoastcta.com
Study Coordinator, alex@gulfcoastcta.com
- Recruiting
Avant Concierge Urology
Winter Garden, Florida, 34787
Sijo Parekattil, MD, 407-547-1654, sijo@avantconciergeurol.com
Study Coordinator, alana@avantconciergeurol.com
About this study
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)
- Being tested
- Zenflow Spring System
- Keywords
- Benign Prostatic Hyperplasia (BPH), Symptomatic BPH, BPH, Benign Prostatic Hyperplasia, enlarged prostate, lower urinary tract symptoms (LUTS), LUTS
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenflow Spring SystemDevice
Minimally Invasive Treatment for LUTS associated with BPH
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness - IPSS
The primary effectiveness endpoint is the change in IPSS from baseline over time
Measured: Baseline to 12 Months
Safety - adverse events
The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs)
Measured: Baseline to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start29 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Zenflow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538622
- Sponsor's protocol ID
- CLIN-0297
- Status last verified
- Aug 2026
- First submitted
- 13 Apr 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry
- ClinicalTrials.gov ID
- NCT07538622
- Acronym / sponsor ID
- CLIN-0297
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Keywords
- Benign Prostatic Hyperplasia (BPH), Symptomatic BPH, BPH, Benign Prostatic Hyperplasia, enlarged prostate, lower urinary tract symptoms (LUTS), LUTS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zenflow, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
Key inclusion criteria (1 listed)
- Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Key exclusion criteria (1 listed)
- Treatment with Zenflow Spring System will be conducted in accordance with the approved Instructions for Use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zenflow Spring SystemMinimally Invasive Treatment for LUTS associated with BPH | Device | – |
Primary outcome
Effectiveness - IPSS
Time frame: Baseline to 12 Months
The primary effectiveness endpoint is the change in IPSS from baseline over time
Safety - adverse events
Time frame: Baseline to 12 Months
The primary safety endpoint is the observed rate of device-related serious adverse events (SAEs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gulf Coast Clinical Trial Associates / Florida Urology Partners
Tampa, United States
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BPH (Benign Prostatic Hyperplasia), run by Zenflow, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness - IPSS (time frame: Baseline to 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.