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Black Star - Magnetic Stent Removal in Transplant Patients

NCT ID: NCT03143556

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2018-11-30

Brief Summary

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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

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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

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Kidney Failure, Chronic End Stage Renal Failure With Renal Transplant

Keywords

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renal transplant magnetic ureteral stent Black-Star®

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Magnetic stent

Intervention Type DEVICE

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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Black-Star®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Anil Kapoor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 25137344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9838320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16249733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17430402 (View on PubMed)

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.

Reference Type RESULT
PMID: 15476491 (View on PubMed)

Other Identifiers

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07282016

Identifier Type: -

Identifier Source: org_study_id