Blue Halo Coil Catheter for Urinary Retention
(BlueHaloCoil Trial)
Trial Summary
What is the purpose of this trial?
This trial studies a special tube called the Blue Halo Coil Catheter, designed to help men with an enlarged prostate who have trouble urinating. The device helps drain the bladder more effectively and is used temporarily for a few weeks.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking LHRH analogs or anti-androgen drugs, you cannot participate in the trial.
What data supports the effectiveness of the Blue Halo Coil Catheter treatment for urinary retention?
The research suggests that alternative techniques like the prostatic coil can be effective for patients with urinary retention, as they avoid the complications associated with long-term use of traditional catheters. A study showed that a similar coil was successfully positioned in 21 out of 25 patients on the first attempt, indicating a promising success rate.12345
Is the Blue Halo Coil Catheter safe for humans?
How does the Blue Halo Coil Catheter treatment differ from other treatments for urinary retention?
The Blue Halo Coil Catheter is unique because it offers an alternative to traditional indwelling catheters by using a coil that can be placed with the help of transrectal sonography, potentially reducing the need for permanent catheters and surgery. This approach may allow patients to void naturally and maintain continence, which is not always possible with standard catheters.2591011
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Blue Halo Coil Catheter for bladder drainage for up to 28 days
Follow-up
Participants are monitored for safety and effectiveness after device removal
Treatment Details
Interventions
- Blue Halo Coil Catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Blue Halo Biomedical, LLC
Lead Sponsor