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Butterfly Pivotal Study
NCT05341661 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05341661
The ClinicalTrials.gov registry entry for NCT05341661 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Butterfly Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05341661 reports 3 study locations spanning 2 distinct geographic areas — top geographies include New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05341661?
The interventions under investigation include: Butterfly Prostatic Retraction Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05341661?
This trial is sponsored by Butterfly Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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