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Device
Blue Halo Coil Catheter for Urinary Retention for Urinary Retention (BlueHaloCoil Trial)
N/A
Recruiting
Research Sponsored by Blue Halo Biomedical, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights
BlueHaloCoil Trial Summary
This trial will study a device to help men with BPH urinary retention return to volitional voiding and lower their post-void residual.
Who is the study for?
Men over 50 with urinary retention due to BPH, who have a post void residual >350cc and prostate volume >50cc or urethral length of 5+ cm. They must be able to consent and attend appointments. Excluded are those with urethral strictures, gross hematuria, cognitive impairments, history of prostate cancer, high PSA density (>0.1), or on certain prostate medications.Check my eligibility
What is being tested?
The trial is testing the 'Blue Halo Coil Catheter' in men who can't empty their bladders fully because of an enlarged prostate (BPH). The goal is for participants to resume normal urination with less than 75 cc left after voiding.See study design
What are the potential side effects?
Potential side effects may include discomfort during catheter use, urinary tract infections from repeated catheterization, possible injury to the urethra or bladder, and irritation leading to increased urgency or frequency of urination.
BlueHaloCoil Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in Post Void Residual from baseline to day 28 will be measured and reported
Secondary outcome measures
Primary safety endpoint adverse event and device removal
Secondary Safety Endpoint 1, incidence of device encrustation at removal
Secondary Safety Endpoint 2,urinary obstruction due to device migration
+1 moreOther outcome measures
Bacterial Infection Monitoring
Quality of Life Measurement, no scale to report
Trends in Renal Function
+1 moreBlueHaloCoil Trial Design
1Treatment groups
Experimental Treatment
Group I: Blue Halo Coil Catheter for Urinary RetentionExperimental Treatment1 Intervention
The indication for use of the Blue Halo Coil Catheter is to facilitate bladder drainage in adult male patients with urinary retention due to benign prostatic hyperplasia. The device is inserted for temporary use up to 28 days.
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Who is running the clinical trial?
Blue Halo Biomedical, LLCLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have trouble fully emptying my bladder, leaving more than 350 cc.I have visible blood in my urine.I am a man over 50 years old.I am able to understand and agree to the study's requirements.I have a history of prostate cancer.My urinary issues are due to an enlarged prostate.I am currently taking hormone therapy for cancer.I am currently taking alpha-blockers or 5-alpha-reductase inhibitors.I will undergo a biopsy for my prostate nodule to check for cancer.I have a PSA over 4 and density over 0.1, and will undergo a biopsy to check for prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Blue Halo Coil Catheter for Urinary Retention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are any new participants being accepted into this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this research is actively recruiting, commencing on August 1st 2022 and last amended on January 26th 2023. It requires 95 individuals to enrol from 3 distinct locations."
Answered by AI
What is the cap on participants for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical experiment was first advertised on August 1st 2022 and is currently recruiting participants. 95 patients need to be enrolled from 3 separate locations."
Answered by AI
Who else is applying?
What site did they apply to?
Florida Urology Partners
What portion of applicants met pre-screening criteria?
Did not meet criteria
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