NCT03143556

Black Star - Magnetic Stent Removal in Transplant Patients

Comparison of Cystoscopic Removal Versus Magnetic Device Removal of Ureteral Stents in Renal Transplant Recipients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure, Chronic
• End Stage Renal Failure With Renal Transplant

Interventions

Type	Name	Description
DEVICE	Magnetic stent	Patients who are undergoing renal transplant surgery for the treatment of end stage renal failure will be assigned to magnetic stent or routine stent using computer generated randomization method in the operating room. Those who receive magnetic stent would get their stent removal by magnetic device retrieval and not by routine cystoscopy.

Timeline

• Start date: 2017-05-29
• Primary completion: 2018-06-30
• Completion: 2018-11-30
• First posted: 2017-05-08
• Last updated: 2021-12-16

Locations

1 site across 1 country: Canada