NCT05714488

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Blue Halo Biomedical, LLC · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Study participants will have a history of Foley catheter use or self-catheterization to drain their bladder.Participants may include men in urinary retention with no prior intervention. The hypothesis is that the Blue Halo Coil Catheter will reduce the post void residual to \<75 cc with volitional voiding. The Blue Halo Coil Catheter is comprised of a Coiled Retention portion with a guidewire accommodating tip, a short prostate catheter segment, and a pusher/delivery catheter segment, that when left in place allows for the temporary collection of urine prior to conversion to short segment without an external collection device. The tip of the Blue Halo Coil Catheter utilizes a horizontal coil retention device. A monofilament suture is attached to the prostate catheter segment to allow for ease of positioning and removal. The suture also allows for repositioning should the device slip back into the bladder.

Conditions

• Urinary Retention

Interventions

Type	Name	Description
DEVICE	blue halo coil catheter	device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2023-02-06
• Last updated: 2024-01-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study