Last reviewed · How we verify
NCT06849258: RAPID-III
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
NA trial testing FloStent in Benign Prostatic Hyperplasia in 215 participants. Currently enrolling.
31 December 2032
Quick facts
| Lead sponsor | Rivermark Medical |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 215 |
| Start date | 10 February 2025 |
| Primary completion | 31 December 2032 |
| Estimated completion | 31 December 2032 |
| Sites | 20 locations across United States, Australia |
Drugs / interventions tested
- FloStent
- Sham (Control)
Conditions studied
- Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
Sponsor
Rivermark Medical
Who can join
45 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 study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
State-of-the-art in minimally invasive treatments for benign prostatic obstruction.
Grossmann NC, Berjaoui MB, Choudhary O, Pradere B, et al · · 2026 · PMID 41469901 · DOI 10.4111/icu.20250390
Verify or expand the search:
- PubMed search for NCT06849258
- 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
- NCT06759194 — HoLEP vs BipolEP in Management of BPH Patients With Large Prostates · NA · recruiting
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 NCT06849258 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rivermark Medical
- Last refreshed: 27 April 2025
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/NCT06849258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing