The Zenflow Spring System EU Safety and Performance Study
(ZEST EU Trial)
Recruiting at4 trial locations
PG
Overseen byPeter Gilling, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Zenflow, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
Research Team
PG
Peter Gilling, MD
Principal Investigator
Tauranga Urology Research Ltd.
Eligibility Criteria
Inclusion Criteria
Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS) or abdominal ultrasound, measured within past 90 days and prostatic urethral length between 2.5- 4.5 cm
Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS
Baseline PSA <= 2.5ng/mL
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Treatment Details
Interventions
- Zenflow Spring System (Device)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Zenflow Spring SystemExperimental Treatment1 Intervention
Receives treatment with the investigational device
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Who Is Running the Clinical Trial?
Zenflow, Inc.
Lead Sponsor
Trials
5
Recruited
440+