Kidney Failure, ChronicNCT03143556
Black Star - Magnetic Stent Removal in Transplant Patients
A study testing Magnetic stent in people with Kidney Failure, Chronic and End Stage Renal Failure With Renal Transplant, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, End Stage Renal Failure With Renal Transplant
- What is being tested?
- Magnetic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years of age and capable of giving informed consent
- Patients scheduled for deceased donor renal transplant surgery
Who cannot join
- 1) Patients undergoing Live donor renal transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Magnetic stent
- Keywords
- renal transplant, magnetic ureteral stent, Black-Star®
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic stentDevice
Also called Black-Star®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 weeks
Secondary outcomes (3)
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.
Measured: Baseline (intraoperatively)
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.
Measured: 3-6 weeks
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
Measured: 3-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start29 May 2017
- Primary completion30 Jun 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Kapoor, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143556
- Sponsor's protocol ID
- 07282016
- Status last verified
- May 2019
- First submitted
- 5 Apr 2017
- Last updated
- 16 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25137344Kumar 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.
PubMed 9838320Wilson 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.
PubMed 16249733Englesbe 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.
PubMed 17430402Mangus 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.
PubMed 15476491
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cystoscopic Removal Versus Magnetic Device Removal of Ureteral Stents in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT03143556
- Acronym / sponsor ID
- 07282016
- Keywords
- renal transplant, magnetic ureteral stent, Black-Star®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 29 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Stent | Experimental | Device: Magnetic stentPatients 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients at least 18 years of age and capable of giving informed consent
- Patients scheduled for deceased donor renal transplant surgery
Key exclusion criteria (1 listed)
- 1) Patients undergoing Live donor renal transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic stentAlso: Black-Star®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. | Device | Magnetic Stent |
Primary outcome
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 secondary outcomes
Outcome measure: Retrieval time
Time frame: Baseline (intraoperatively)
Outcome measure: Infection rate
Time frame: 3-6 weeks
Outcome measure: Cost effectiveness
Time frame: 3-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Background: PubMed 25137344Theckumparampil 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.
- Background: PubMed 9838320Kumar 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.
- Background: PubMed 16249733Wilson 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.
- Background: PubMed 17430402Englesbe 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.
- Results publication: PubMed 15476491Mangus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic stent in people with Kidney Failure, Chronic and End Stage Renal Failure With Renal Transplant, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and patient comfort of the retrieval device, using standard validated questionnaire Ureteral Stent Symptom Questionnaire (USSQ) (time frame: 3-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143556, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.