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Prostatic Retraction Device

Butterfly Device for Lower Urinary Tract Symptoms

N/A

Recruiting

Research Sponsored by Butterfly Medical Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate volume 30-90 ml

Male patient age 50 to 80

Must not have

Active stone disease (urinary stone increase in size during the last 3 months/ stone passage during the last 3 months/ presence of cystolithiasis)

Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

Summary

This trial is studying if a device called the Butterfly is better than a sham procedure at treating urinary symptoms in men.

Who is the study for?

Men aged 50-80 with benign prostatic hyperplasia (BPH), experiencing moderate to severe urinary symptoms, and a prostate size of 30-90 ml. Candidates must not have had prior prostate surgery or suffer from conditions like uncontrolled diabetes, neurological disorders, or active bladder issues. They should not be on certain medications for BPH or have a history of prostate cancer.

What is being tested?

The Butterfly Pivotal Study is testing the effectiveness of the Butterfly Prostatic Retraction Device in improving urinary symptoms in men with BPH. Participants are randomly assigned to either receive this device treatment or undergo a sham procedure without actual treatment.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include discomfort during the procedure, possible infection risk due to instrumentation, and individual reactions to the device material if there's an allergy to nickel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate size is between 30 to 90 ml.

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I am a man aged between 50 and 80.

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I have symptoms of an enlarged prostate with a score of 13 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had kidney stones grow, pass, or bladder stones in the last 3 months.

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I have had or currently have a narrowing in my urinary passage.

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My bladder and prostate shape allow for safe surgical equipment use.

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I currently have a serious urinary tract infection.

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I have issues emptying my bladder that may be due to nerve problems.

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I am currently unable to empty my bladder completely.

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My prostate has a significant growth into my bladder.

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My bladder test results show low flow, incomplete emptying, or small void volume.

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I have a urethral condition like a blockage, growth, or abnormal connection.

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I currently have an active bladder tumor.

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I have a bleeding disorder that is not under control.

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I frequently urinate more than usual, especially at night.

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I experience urine leakage when I cough or sneeze.

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I have had chronic prostatitis, CPPS, or painful bladder syndrome in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score.

Change in active arm International Prostate Symptom Score (IPSS) from baseline to 12 months

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Cross overExperimental Treatment1 Intervention

Sham arm patient is allowed to crossover and undergo the Butterfly procedure

Group II: ActiveActive Control1 Intervention

The active arm patients undergo the Butterfly device procedure.

Group III: Sham ComparatorPlacebo Group1 Intervention

The sham control arm patients undergo a rigid cystoscopy procedure.

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Butterfly Medical Ltd.Lead Sponsor

2 Previous Clinical Trials

152 Total Patients Enrolled

Adrian Paz, MDStudy DirectorMedical director

Media Library

Butterfly Prostatic Retraction Device (Prostatic Retraction Device) Clinical Trial Eligibility Overview. Trial Name: NCT05341661 — N/A

Benign Prostatic Hyperplasia Research Study Groups: Active, Sham Comparator, Cross over

Benign Prostatic Hyperplasia Clinical Trial 2023: Butterfly Prostatic Retraction Device Highlights & Side Effects. Trial Name: NCT05341661 — N/A

Butterfly Prostatic Retraction Device (Prostatic Retraction Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05341661 — N/A

~69 spots leftby Nov 2025

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