A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

Part of paid clinical trials in Bakersfield, California.

Sponsor
Rivermark Medical
Study ID
NCT06849258
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FloStent — DEVICE
    Flexible cystoscopy to deploy medical device used to treat BPH
  • Sham (Control) — DEVICE
    Flexible Cystoscopy without deployment of medical device used to treat BPH

Study Details

The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.

Key Dates

Start date
Feb 10, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2032
Completion
Dec 31, 2032

Study Design

Enrollment
215 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment - FloStent
    Flexible cystoscopy procedure with FloStent implant deployed
  • Sham Comparator: Sham Control
    Flexible cystoscopy procedure without FloStent implant deployed

Primary Outcome Measure

Change in International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Michael G Oefelein Clinical TrialsBakersfieldCalifornia93301-
Comprehensive Urology Medical GroupBeverly HillsCalifornia90048-
Atlas Men's HealthLa MesaCalifornia91942-
Urology Group of Southern CaliforniaLos AngelesCalifornia90017-
Alarcon Urology CenterMontebelloCalifornia90640-
Prestige Medical GroupTustinCalifornia92780-
Urology DenverLittletonColorado80122-
Advanced Urology InstituteDaytona BeachFlorida32114-
Duly HealthLisleIllinois60532-
Southern UrologyLafayetteLouisiana70508-
Michigan Institute of UrologyTroyMichigan48084-
Sheldon Freedman UrologyLas VegasNevada89144-
Manhattan Medical Research NYU LangoneNew YorkNew York10016-
Northwell HealthSyossetNew York11791-
Associated Urologists of North CarolinaRaleighNorth Carolina27612-
Conrad Pearson ClinicGermantownTennessee38138-
Midtown Urology AssociatesAustinTexas78705-
Urology Austin/Urology AmericaAustinTexas78759-
Houston MethodistHoustonTexas77030-

Find similar trials in Bakersfield, CA

By research site
Michael G Oefelein Clinical Trials· Bakersfield, CAComprehensive Urology Medical Group· Beverly Hills, CAAtlas Men's Health· La Mesa, CAUrology Group of Southern California· Los Angeles, CAAlarcon Urology Center· Montebello, CAPrestige Medical Group· Tustin, CA

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