Black Star - Magnetic Stent Removal in Transplant Patients

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143556
• Other study ID #: 07282016
• Status: Completed
• Phase: N/A
• Start date: May 29, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: May 2019
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. Epub 2007 Apr 8. — View 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. — View Citation

Mangus RS, Haag BW. Stented versus nonstented extravesical ureteroneocystostomy in renal transplantation: a metaanalysis. Am J Transplant. 2004 Nov;4(11):1889-96. Review. — View 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. — View Citation

Wilson CH, Bhatti AA, Rix DA, Manas DM. Routine intraoperative stenting for renal transplant recipients. Transplantation. 2005 Oct 15;80(7):877-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and patient comfort of the retrieval device, using standard validated questionnaire Ureteral Stent Symptom Questionnaire (USSQ)	All patients will be followed up 4 weeks post renal transplant surgery, until ureteral stent removal. Feasibility and comfort of stent retrieval, Ureteral Stent Symptom Questionnaire (USSQ) at 4 weeks before stent removal and 1 week post stent removal.	3-6 weeks
Secondary	Outcome measure: Retrieval time	Retrieval time in minutes: The time taken for ureteric stent removal (both routine and magnetic stent) will be documented and mean time taken will be calculated. This will show which technique takes less time.	Baseline (intraoperatively)
Secondary	Outcome measure: Infection rate	Infection rates: Number of Urine culture positive with stent in situ and after removal of stent (both routine and magnetic stent). This will suggest if magnetic stent is associated with an increased incidence of urinary tract infections as compared to the routine stent.	3-6 weeks
Secondary	Outcome measure: Cost effectiveness	Cost effective analysis: Units will be Canadian Dollars; we will analyze the cost of disposables, sterilization of instruments, use of cystoscopy suite and also nursing and surgeon charges. Mean cost taken for either procedure will be compared to find cost effectiveness	3-6 weeks