Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT03143556
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2017-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Black Star - Magnetic Stent Removal in Transplant Patients
Sponsor:
St. Joseph's Healthcare Hamilton
Organization:
Study Overview
Official Title:
Comparison of Cystoscopic Removal Versus Magnetic Device Removal of Ureteral Stents in Renal Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2019-05
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:
None
Brief Summary:
This is a pilot, single-centre, feasibility study to assess the feasibility issues and collect preliminary clinical data for the design of future randomized controlled trial to evaluate the feasibility and patient comfort of magnetic retrieval device removal of ureteral stent in transplant patients.
Detailed Description:
To curtail the pain and discomfort during cystoscopic stent removal and in order to improve patient's quality of life, a newly developed ureteral stent with a small magnet at its distal end and a customized magnetic retrieval catheter is recently used in Europe. The product is Black-Star® with a retrieval device by Urotech (Achenmühle, Germany). The magnetic Blackstar stent is a ureteral stent with a small magnet fixed with a string at the distal loop. The placement of stent is similar as routinely done on a guidewire, the only difference is to include the magnetic piece over the guidewire. To remove the stent a customized catheter with a magnetic Tiemann tip is used. The catheter is inserted after urethral application of a standard lubricant and removed with the stent after coming in contact with the stent's magnet.
The stent comes in various sizes and is currently being used in Europe. The studies have concluded fast and easy retrieval of stent without requirement of cystoscopy and decreased patient discomfort.
The stent comes in various sizes and is currently being used in Europe. The studies have concluded fast and easy retrieval of stent without requirement of cystoscopy and decreased patient discomfort.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: