Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC Blue Halo Coil Catheter for Patients With Prostatic Obstruction
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The Investigators will study a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent or who have a Post Void Residual \> 350cc. The hypothesis is that the device will allow these participants to return to volitional voiding with a Post Void Residual \<75 cc.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: t
View:
• 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
Locations
United States
Alabama
The University of Alabama-Birmingham
RECRUITING
Birmingham
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
Florida
Florida Urology Partners
RECRUITING
Brandon
Vero Urology Center
RECRUITING
Vero Beach
Contact Information
Primary
GAMEEL B HODGE, MD
bhodge@bluehalobiomedical.com
407-492-1683
Backup
GAINES W HAMMOND, MD
gwhoffice@gmail.com
254-652-2475
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2024-10-01
Participants
Target number of participants: 95
Treatments
Experimental: Blue Halo Coil Catheter for Urinary Retention
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.
Related Therapeutic Areas
Sponsors
Leads: Blue Halo Biomedical, LLC