RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction

Quick Facts

Study Start:2022-08-01
Study Completion:2024-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05714488

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male subjects \> 50 years of age
  2. * Able to provide consent
  3. * Participants in urinary retention with post void residual \> 350 cc
  4. * Urinary retention is due to BPH with a prostate volume \> 50cc or a prostatic urethral length of 5+ cm
  5. * Subjects with a PSA \> 4 ng/ml and a PSA density of 0.1 or less
  6. * Subjects on alpha- blocking drugs or 5-alpha-reductase inhibitor drugs may be included
  7. * Inability to undergo bladder catheterization ( i.e. urethral stricture)
  8. * Presence of gross hematuria
  9. * Lack of cognitive ability to give consent or keep appointments
  10. * History of Prostate Cancer
  11. * 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
  12. * A subject with a prostate nodule will require biopsy to exclude cancer diagnosis
  13. * Subject with a PSA \> 10 ng/ml
  14. * Subject taking LHRH analogs or anti-androgen drugs
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

GAMEEL B HODGE, MD
CONTACT
407-492-1683
bhodge@bluehalobiomedical.com
GAINES W HAMMOND, MD
CONTACT
254-652-2475
gwhoffice@gmail.com

Study Locations (Sites)

The University of Alabama-Birmingham
Birmingham, Alabama, 35205
United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054
United States
Florida Urology Partners
Brandon, Florida, 33511
United States
Vero Urology Center
Vero Beach, Florida, 32960
United States

Collaborators and Investigators

Sponsor: Blue Halo Biomedical, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-01
Study Completion Date2024-10-01

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2024-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Urinary Retention