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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 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. The trial reports 3 study locations across 2 states.
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
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 |
Interested in This Trial?
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, categorized as NA. 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.
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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.
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