Clinical trial NCT03143556: Black Star - Magnetic Stent Removal in Transplant Patients
Official title: Comparison of Cystoscopic Removal Versus Magnetic Device Removal of Ureteral Stents in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
End Stage Renal Failure With Renal Transplant
Keywords: renal transplant
magnetic ureteral stent
Black-Star®
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Patients at least 18 years of age and capable of giving informed consent
2. Patients scheduled for deceased donor renal transplant surgery

Exclusion Criteria:

1) Patients undergoing Live donor renal transplant

Primary outcomes:
measure: Feasibility and patient comfort of the retrieval device, using standard validated questionnaire Ureteral Stent Symptom Questionnaire (USSQ)
timeFrame: 3-6 weeks
Secondary outcomes:
measure: Outcome measure: Retrieval time
timeFrame: Baseline (intraoperatively)
measure: Outcome measure: Infection rate
timeFrame: 3-6 weeks
measure: Outcome measure: Cost effectiveness
timeFrame: 3-6 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References:
citation: Theckumparampil N, Elsamra SE, Carons A, Salami SS, Leavitt D, Kavoussi A, Motola J, Smith A, Okeke Z. Symptoms after removal of ureteral stents. J Endourol. 2015 Feb;29(2):246-52. doi: 10.1089/end.2014.0432. Epub 2014 Sep 17.
citation: Kumar A, Kumar R, Bhandari M. Significance of routine JJ stenting in living related renal transplantation: a prospective randomised study. Transplant Proc. 1998 Nov;30(7):2995-7. doi: 10.1016/s0041-1345(98)00902-6. No abstract available.
citation: Wilson CH, Bhatti AA, Rix DA, Manas DM. Routine intraoperative stenting for renal transplant recipients. Transplantation. 2005 Oct 15;80(7):877-82. doi: 10.1097/01.tp.0000181197.21706.fa.
citation: Englesbe MJ, Dubay DA, Gillespie BW, Moyer AS, Pelletier SJ, Sung RS, Magee JC, Punch JD, Campbell DA Jr, Merion RM. Risk factors for urinary complications after renal transplantation. Am J Transplant. 2007 Jun;7(6):1536-41. doi: 10.1111/j.1600-6143.2007.01790.x. Epub 2007 Apr 8.
citation: Mangus RS, Haag BW. Stented versus nonstented extravesical ureteroneocystostomy in renal transplantation: a metaanalysis. Am J Transplant. 2004 Nov;4(11):1889-96. doi: 10.1111/j.1600-6143.2004.00595.x.