Trials / Active Not Recruiting
Active Not RecruitingNCT05400980
Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath
The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross® Expander System and Retrieval Sheath
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- Sponsor
- Prodeon Medical, Inc · Industry
- Sex
- Male
- Age
- 45 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Urocross implant | Urocross implant inserted via delivery catheter |
| DIAGNOSTIC_TEST | Sham-control | Cystoscopy |
Timeline
- Start date
- 2022-07-05
- Primary completion
- 2025-09-01
- Completion
- 2028-12-01
- First posted
- 2022-06-02
- Last updated
- 2025-04-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05400980. Inclusion in this directory is not an endorsement.