The Zenflow Spring System Safety and Performance Study (ZEST CAN)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 45
Healthy Volunteers: f
View:
• Patient is able and willing to comply with all the assessments of the study
• Patient or patient's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form
• ≥ 45 years of age
• Baseline IPSS score \> 13
• Prostate volume 25 - 80 cc and prostatic urethral length between 2.5-4.5 cm measured within the past 90 days
• Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS
Locations
Other Locations
Canada
Groupe Sante Brunswick
RECRUITING
Pointe-claire
Toronto Western Hospital
RECRUITING
Toronto
Contact Information
Primary
Emily Hu
emily@zenflow.com
5109098237
Backup
Kevin MacDonald
kfmacdonald@zenflow.com
415-609-9875
Time Frame
Start Date: 2021-02-09
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 40
Treatments
Experimental: Treatment Group
Receives intervention with the Zenflow Spring System.
Related Therapeutic Areas
Sponsors
Leads: Zenflow, Inc.