Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05714488
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2022-09-20
Brief Title:
Evaluation of the Blue Halo Coil Catheter for Patients With Prostatic Obstruction
Sponsor:
Blue Halo Biomedical LLC
Organization:
Blue Halo Biomedical LLC
Study Overview
Official Title:
Study A Prospective Evaluation of the Blue Halo BioMedical LLC Blue Halo Coil Catheter for Patients With Prostatic Obstruction
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BlueHaloCoil
Brief 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 bladderParticipants 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 pusherdelivery 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
Study participants will have a history of Foley catheter use or self-catheterization to drain their bladderParticipants 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 pusherdelivery 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None