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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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Who is running the clinical trial?
Butterfly Medical Ltd.Lead Sponsor
2 Previous Clinical Trials
120 Total Patients Enrolled
Adrian Paz, MDStudy DirectorMedical director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had kidney stones grow, pass, or bladder stones in the last 3 months.My prostate length is between 25mm and 45mm.I think I have an overactive bladder.I have had or currently have a narrowing in my urinary passage.My bladder and prostate shape allow for safe surgical equipment use.I currently have a serious urinary tract infection.I have issues emptying my bladder that may be due to nerve problems.I've had prostate surgery or a procedure, but not significant fibrosis.I am currently unable to empty my bladder completely.My PSA is over 10 ng/mL, or I might have prostate cancer.My prostate has a significant growth into my bladder.My prostate length is between 25mm and 45mm.I have taken phenylephrine or pseudoephedrine within the last 24 hours.My bladder test results show low flow, incomplete emptying, or small void volume.I have been taking specific medications for bladder or prostate issues, or hormone treatments.I do not have any conditions that would prevent me from completing the study or affect its results.I have a condition like diabetes or Parkinson's that affects my bladder control.I have a urethral condition like a blockage, growth, or abnormal connection.My prostate size is between 30 to 90 ml.I currently have an active bladder tumor.You have a condition where the opening of your bladder is blocked, and it is difficult for you to urinate.I have a bleeding disorder that is not under control.I frequently urinate more than usual, especially at night.I have not taken 5 alpha reductase inhibitors in the last 6 months.I am a man aged between 50 and 80.You are allergic to nickel.I have symptoms of an enlarged prostate with a score of 13 or more.I had a prostate biopsy in the last 6 weeks.I experience urine leakage when I cough or sneeze.I have had chronic prostatitis, CPPS, or painful bladder syndrome in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Sham Comparator
- Group 3: Cross over
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit of this trial younger than 45 years?
"The parameters of this medical trial demand that participants must be between the ages of 50 and 80. Furthermore, there are 30 studies for patients below 18 years old, as well as 122 trials available to those over 65."
Answered by AI
How many people are participating in this research endeavor?
"Affirmative. Based on information available from clinicaltrials.gov, this trial is actively seeking candidates and was first posted on April 7th 2022 with its last update occurring May 31st of the same year. To complete the study, 222 participants are required at two distinct sites."
Answered by AI
To whom is this research open?
"Clinical researchers are currently seeking 222 male patients aged 50 to 80 who present with lower urinary tract symptoms. All participants must be willing and able to sign informed consent, abide by the assessments of the study, have a prostate volume between 30-90ml, an IPSS score ≥ 13 or greater in its voiding sub-score ratio (IPSS-V/ S), a prostate length ranging from 25mm - 45 mm (from apex of the prostate to beginning of bladder neck)."
Answered by AI
Are there any current opportunities to join this clinical exploration?
"Indeed, the information published on clinicaltrials.gov confirms that this study is recruiting patients at present. Originally posted on April 7th 2022, it was recently updated in May 2021 and seeks to recruit 222 participants from 2 locations."
Answered by AI
Who else is applying?
What state do they live in?
Utah
How old are they?
65+
What site did they apply to?
Summit Urology
What portion of applicants met pre-screening criteria?
Met criteria
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