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The Zenflow Spring System Safety, Performance and Effectiveness Study

NCT03595735 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-22

No results posted yet for this study

Summary

This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Zenflow Spring System

The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.

Sponsors & Collaborators

  • Zenflow, Inc.

    lead INDUSTRY

Principal Investigators

  • Juan J Galan, MD · Centro de Urología Avanzada del Noreste (CUAN)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2020-12-30
Completion
2024-03-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03595735 on ClinicalTrials.gov