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Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath

NCT05400980 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-04-09

No results posted yet for this study

Summary

To demonstrate the safety and efficacy of the Urocross Expander System/Retrieval Sheath and the procedure to treat patients with symptomatic Benign Prostatic Hyperplasia (BPH).

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Urocross implant

Urocross implant inserted via delivery catheter

DIAGNOSTIC_TEST

Sham-control

Cystoscopy

Sponsors & Collaborators

  • Prodeon Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Kevin T. McVary · Loyola University

  • Daniel B. Rukstalis · Carilion Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2025-09-30
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

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 NCT05400980 on ClinicalTrials.gov