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Safety and Feasibility of the XFLO Expander System (Mercury)

NCT03758222 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-07-26

No results posted yet for this study

Summary

To demonstrate the safety and feasibility of the Mercury Expander system and procedure to treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

XFLO Expander System

Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)

Sponsors & Collaborators

  • MedeonBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Henry Woo, MD · Australian Clinical Trials Pty Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2022-12-31
Completion
2025-08-31
FDA Device
Yes

Countries

  • Australia
  • Canada
  • Georgia
  • Taiwan

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 NCT03758222 on ClinicalTrials.gov