4 active not recruiting, 4 completed, 2 recruiting, 1 withdrawn. 7 Not applicable, 1 Early Phase 1, 1 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 7 | Active not recruiting 2, Completed 2, Recruiting 2, Withdrawn 1 |
| Early Phase 1 | 1 | Completed 1 |
| Phase 2 | 1 | Completed 1 |
| Phase 4 | 1 | Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures Optilume - Ureteral Stricture | Not applicable | Recruiting | Urotronic Inc. | 60 | 2025-10-01 | 2026-03-09 |
| OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH Data collection - Benign Prostatic Hyperplasia | Active not recruiting | Urotronic Inc. | 500 | 2024-03-30 | 2026-07-10 | |
| Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study Optilume® BPH Catheter System - Benign Prostatic Hyperplasia | Not applicable | Recruiting | Urotronic Inc. | 92 | 2024-02-07 | 2026-07-10 |
| Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH) Optilume Catheter System - Benign Prostatic Hyperplasia | Not applicable | Completed | Dean Elterman | 30 | 2023-03-07 | 2026-08-19 |
| Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters Optilume Urethral DCB - Urethral Stricture | Phase 4 | Active not recruiting | Urotronic Inc. | 34 | 2022-02-14 | 2026-09-21 |
| Optilume™ BPH Catheter System in Men With Symptomatic BPH Optilume BPH Catheter System, Optilume Sham Device - Benign Prostatic Hyperplasia | Not applicable | Active not recruiting | Urotronic Inc. | 162 | 2020-02-05 | 2026-07-30 |
| Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study Optilume Drug Coated Balloon - Urethral Stricture, Urethral Stricture, Anterior | Not applicable | Withdrawn | Urotronic Inc. | 2019-05-31 | 2019-07-12 | |
| ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease Optilume Drug Coated Balloon (DCB), Control Treatment - Urethral Stricture | Not applicable | Active not recruiting | Urotronic Inc. | 127 | 2018-06-22 | 2026-05-19 |
| Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter Optilume™ BPH Prostatic DCB Dilation Catheter, Paclitaxel - Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy | Phase 2 | Completed | Urotronic Inc. | 80 | 2017-12-19 | 2025-11-26 |
| Re-establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease Urotronic Drug Coated Balloon (DCB) - Urethral Stricture | Not applicable | Completed | Urotronic Inc. | 16 | 2017-10-25 | 2025-11-26 |
| ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease Urotronic Drug Coated Balloon (DCB) - Stricture Urethra | Early Phase 1 | Completed | Urotronic Inc. | 53 | 2016-11-01 | 2024-03-22 |
Prostatic Hyperplasia (5) · Urethral Stricture (5) · Lower Urinary Tract Symptoms (2) · Bites and Stings (1) · Color Vision Defects (1) · Constriction, Pathologic (1) · Urinary Tract Infections (1)
Data Collection (1) · Paclitaxel (1)
United States (8) · Canada (3) · Dominican Republic (1) · Panama (1)
Sean Elliott, MD (2) · Ian Schorn (1) · Jamie Landman, MD (1) · Jill Moland (1) · Karl Coutinho, MD (1) · Ramon Virasoro, MD (1) · Ron Kodama, MD (1) · Steven A Kaplan, MD (1) · Steven Kaplan, MD, FACS (1)