NCT03143556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

May 29, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

December 16, 2021

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

April 5, 2017

Last Update Submit

December 14, 2021

Conditions

Kidney Failure, ChronicEnd Stage Renal Failure With Renal Transplant

Keywords

renal transplantmagnetic ureteral stentBlack-Star®

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Outcome measure: Retrieval time

    Baseline (intraoperatively)

  • Outcome measure: Infection rate

    3-6 weeks

  • Outcome measure: Cost effectiveness

    3-6 weeks

Study Arms (2)

Magnetic Stent

EXPERIMENTAL

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

Routine stent

NO INTERVENTION

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

Interventions

Magnetic stentDEVICE

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.

Also known as: Black-Star®
Magnetic Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \) Patients undergoing Live donor renal transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6, Canada

Location

Related Publications (5)

  • 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.

    PMID: 25137344BACKGROUND

  • 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.

    PMID: 9838320BACKGROUND

  • 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.

    PMID: 16249733BACKGROUND

  • 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.

    PMID: 17430402BACKGROUND

  • 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.

    PMID: 15476491RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2017

First Posted

May 8, 2017

Study Start

May 29, 2017

Primary Completion

June 30, 2018

Study Completion

November 30, 2018

Last Updated

December 16, 2021

Record last verified: 2019-05

Locations

CA(1)