Last reviewed · How we verify
NCT03912558
Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in BPH Patients.
NA trial testing Butterfly device implantation in BPH in 92 participants. Completed in 1 April 2024.
1 April 2024
Quick facts
| Lead sponsor | Butterfly Medical Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 29 October 2018 |
| Primary completion | 1 April 2024 |
| Estimated completion | 1 April 2024 |
| Sites | 4 locations across Israel |
Drugs / interventions tested
- Butterfly device implantation
Conditions studied
- BPH — all drugs for BPH →
- BOO - Bladder Outflow Obstruction — all drugs for BOO - Bladder Outflow Obstruction →
Sponsor
Butterfly Medical Ltd.
Who can join
50 and older, male only, with BPH or BOO - Bladder Outflow Obstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) Patients. The study follows patients implanted with the Butterfly device for up to 1 year after implantation. Evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests and International Prostate Symptom Score (IPSS) questionnaires. The study also assess sexual quality of life after implantation of the Butterfly device.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Prostatic stents: a narrative review of current evidence.
Cerrato C, Antoniou V, Napolean Fernandes S, Madaan S, et al · · 2024 · cited 6× · PMID 38826501 · DOI 10.1177/17562872241255262 -
Transformations in Benign Prostatic Hyperplasia Surgical Practices: A Longitudinal Study of Trends and Predictions.
Lifshitz K, Savin Z, Bashi T, Dekalo S, et al · · 2025 · cited 1× · PMID 39362201 · DOI 10.1159/000541752
Verify or expand the search:
- PubMed search for NCT03912558
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for BPH
Currently open trials in the same condition.
- NCT07115147 — Blue Diode Laser Vaporization for BPH · NA · recruiting
- NCT05401032 — Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH. · Phase 2 · recruiting
- NCT05719220 — Effect of Group Preoperative Pelvic Floor Training for HoLEP · recruiting
- NCT05620784 — Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP · Phase 3 · recruiting
- NCT05330520 — Long Term Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Pat · NA · recruiting
Other Butterfly Medical Ltd. trials
Trials by the same sponsor.
- NCT05341661 — Butterfly Pivotal Study · NA · active not recruiting
- NCT05330520 — Long Term Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Pat · 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 NCT03912558 (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 Butterfly Medical Ltd.
- Last refreshed: 6 August 2024
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/NCT03912558.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing