NCT03758222

Safety and Feasibility of the XFLO Expander System (Mercury)

A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: MedeonBio, Inc. · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the Mercury Expander system in patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia (BPH).

Conditions

• Benign Prostatic Hyperplasia

Interventions

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

Timeline

• Start date: 2018-11-07
• Primary completion: 2022-12-01
• Completion: 2025-08-01
• First posted: 2018-11-29
• Last updated: 2022-07-26

Locations

5 sites across 4 countries: Australia, Canada, Georgia, Taiwan

Regulatory

• FDA-regulated device study