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NCT05341661 · ClinicalTrials.gov registry record · NA
Butterfly Pivotal Study
A NA study of BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms (LUTS), sponsored by Butterfly Medical.
- Active
- Registry status
- NA
- Development phase
- 245
- Enrollment target
- 3
- Study locations
NCT05341661: Active NA study of BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms (LUTS), sponsored by Butterfly Medical.
NCT05341661 is a NA study of BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms (LUTS) that is active but no longer recruiting, run by Butterfly Medical. The registered enrollment target is 245 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05341661, a NA study of BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms (LUTS), is active but no longer recruiting, sponsored by Butterfly Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 245 participants
- Enrollment target
- 3
- Study locations
Study Summary
A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure
Primary Outcome
Analysis will compare the active and control study arms IPSS
Conditions Studied
Interventions
- DEVICE Butterfly Prostatic Retraction Device
Study Locations (3)
New York
- Manhattan Medical Research - New York
- Northwell Health - Syosset
Texas
- Houston Methodist - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2022-04-07 |
| Est. Completion | 2029-12-31 |
| Phase | NA |
What the registry record for NCT05341661 still lists
NCT05341661 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with BPH (Benign Prostatic Hyperplasia) appearing as the primary indexed condition, and to 1 intervention - of which Butterfly Prostatic Retraction Device is the first listed.
NCT05341661 reports a single indexed study location in New York, Texas.
Frequently Asked Questions
What is clinical trial NCT05341661 about?
NCT05341661 is a clinical study titled "Butterfly Pivotal Study". A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Bu...
What is the current status of trial NCT05341661?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 245 participants. The study started on 2022-04-07. Estimated completion is 2029-12-31.
What conditions does trial NCT05341661 study?
This clinical trial studies the following conditions: BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS).
What interventions are being tested in trial NCT05341661?
The interventions under investigation include: Butterfly Prostatic Retraction Device (DEVICE).
Who is sponsoring clinical trial NCT05341661?
This trial is sponsored by Butterfly Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05341661 being conducted?
This trial has 3 study locations across New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for BPH (Benign Prostatic Hyperplasia)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05341661's enrollment target sits among peer trials
245 436th of 2000 higher than 1,563 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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