Last reviewed · How we verify
NCT06312722: PEAK
Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study
NA trial testing Optilume® BPH Catheter System in Benign Prostatic Hyperplasia in 92 participants. Currently enrolling.
7 February 2031
Quick facts
| Lead sponsor | Urotronic Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 7 February 2024 |
| Primary completion | 7 February 2031 |
| Estimated completion | 7 February 2031 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Optilume® BPH Catheter System
Conditions studied
- Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
Sponsor
Urotronic Inc. — full company profile →
Who can join
50 and older, male only, with Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06312722
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Benign Prostatic Hyperplasia
Currently open trials in the same condition.
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- NCT07293442 — Pelvic Floor Muscle Exercise for Lower Urinary Tract Symptoms After Surgery for Benign Prostatic Hyperplasia. · NA · recruiting
- NCT06657872 — Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial · NA · recruiting
- NCT06852859 — Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia · recruiting
- NCT06849258 — A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms · NA · recruiting
Other Urotronic Inc. trials
Trials by the same sponsor.
- NCT07020520 — EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures · NA · recruiting
- NCT06560476 — OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH · recruiting
- NCT05383274 — Optilume PoST AppRoval Clinical Evaluation of Andrology ParaMeters · Phase 4 · recruiting
- NCT03851952 — Re-Establishing Flow Via Drug Coated Balloon for the Treatment of Urethral Stricture Disease - Registry Study · NA · withdrawn
- NCT03423979 — Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06312722 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Urotronic Inc.
- Last refreshed: 14 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06312722.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing