Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction

Launched by BLUE HALO BIOMEDICAL, LLC · Jan 26, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new device called the "Blue Halo Coil Catheter" to help men who have trouble urinating due to a condition called Benign Prostatic Hyperplasia (BPH). The trial is specifically for men over 50 years old who are experiencing urinary retention, meaning they are unable to empty their bladder fully, with a leftover urine amount greater than 350 cc. The goal of the study is to see if this device can help these men urinate more normally, reducing the leftover urine to less than 75 cc.

To be eligible for this trial, participants need to be male, over the age of 50, and able to provide consent. They should have urinary retention caused by BPH and meet specific medical criteria regarding their prostate health. Participants can expect to be closely monitored during the trial, and they will receive the new device to help manage their condition. It's important to note that individuals with certain health issues, like a history of prostate cancer or specific high levels of PSA (a prostate-specific marker), may not qualify for the study. This trial is actively recruiting participants who meet the criteria and are looking for new options to improve their urinary health.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male subjects \> 50 years of age
• • Able to provide consent
• • Participants in urinary retention with post void residual \> 350 cc
• • Urinary retention is due to BPH with a prostate volume \> 50cc or a prostatic urethral length of 5+ cm
• • Subjects with a PSA \> 4 ng/ml and a PSA density of 0.1 or less
• • Subjects on alpha- blocking drugs or 5-alpha-reductase inhibitor drugs may be included
• • Exclusion Criteria
• • Inability to undergo bladder catheterization ( i.e. urethral stricture)
• • Presence of gross hematuria
• • Lack of cognitive ability to give consent or keep appointments
• • History of Prostate Cancer
• • Subject with a PSA \> 4 ng/ml and a PSA density of \> 0.1 will require prostate biopsy to rule out prostate cancer in order to be considered for study enrollment
• • A subject with a prostate nodule will require biopsy to exclude cancer diagnosis
• • Subject with a PSA \> 10 ng/ml
• • Subject taking LHRH analogs or anti-androgen drugs