Black Star - Magnetic Stent Removal in Transplant Patients

December 14, 2021 updated by: Anil Kapoor, St. Joseph's Healthcare Hamilton

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N4A6
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic Stent
Patients who are undergoing renal transplant surgery for the treatment of end stage renal failure and randomized for magnetic stent group will receive magnetic stent and the removal of stent would be done by help of magnetic device.
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.
Other Names:
  • Black-Star®
No Intervention: Routine stent
Patients who are undergoing renal transplant surgery for the treatment of end stage renal failure and randomized for routine stent would receive routine stent and the removal of stent would be done by cystoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and patient comfort of the retrieval device, using standard validated questionnaire Ureteral Stent Symptom Questionnaire (USSQ)
Time Frame: 3-6 weeks
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 Measures

Outcome Measure
Measure Description
Time Frame
Outcome measure: Retrieval time
Time Frame: Baseline (intraoperatively)
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)
Outcome measure: Infection rate
Time Frame: 3-6 weeks
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
Outcome measure: Cost effectiveness
Time Frame: 3-6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Actual)

December 16, 2021

Last Update Submitted That Met QC Criteria

December 14, 2021

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07282016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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