UropathyEFUJANCT04384939
Feasibility of Magnetic-end Double-J Ureteral Stent Use in Children
A study testing magnetic-end Double-J ureteral stent in people with Uropathy and Kidney Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Double-J ureteral stent (DJUS) is one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Uropathy, Kidney Transplantation
- What is being tested?
- magnetic-end Double-J ureteral stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2021to 29 Aug 2023
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child aged between 0 and 17 years and 10 months at the surgery
- Child operated at the Necker hospital for an uropathy or kidney graft need the insertion of JJ ureteral stent
- Parents or legal guardians signed the Informed consent form
- Social insurance affiliation
Who cannot join
- All clinical situation need an MRI
- Contraindication with the experimental medical device (severe infections, obstruction, …)
- For the medico-economic study, a comparative group will be constituted with patients treated with classic ureteral stent in the Necker hospital in the previous years.
- This group will be matched with age (<5 years, 5-12 years and >13years), sex and surgery indication (kidney graft or other).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Safety and Medico-economic Study of Magnetic-end Double-J Ureteral Stent Use in Children
Double-J ureteral stent (DJUS) is one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.
Classically, DJUS are introduced and removed in the operation room, under general anesthesia, using a cystoscope.
Read more
The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop.
To remove the magnetic stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip is inserted into the urethra in the outpatient clinic.
The purpose of this study is to demonstrate the feasibility and safety of magnetic-end Double-J ureteral stent use in children and to perform a medico-economic study.
Read the detailed description
First reported in 1967, ureteral stenting evolved fast until the introduction of the double-J ureteral stent (DJUS) in 1978. It has since become one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.
Many modifications have been introduced to Finney's double-J to reduce stent-related complications and disadvantages, one of which is its removal technique. Classically, DJUS are introduced and removed in the operation room (OR), under general anesthesia (GA), using a cystoscope. Efforts have been made to avoid the second procedure under GA. Preventing the patient from undergoing a second OR experience is not the only issue. For institutions, DJUS removal is time consuming and costly in terms of resources, OR occupancy, and staff. In children, the potential neurotoxicity of repeated exposures to GA, is also a major concern.
Alternatives to surgical removal of DJUS vary from basic solutions such as transurethral string, hook, or other tools, to more complex innovations such as the single use flexible cystoscope, and biodegradable stents. Moreover, some pediatric teams used the externalized pyeloureteral stent as an alternative to DJUS. Using magnet for ureteral stent retrieval was introduced in the early 80s. Difficulties related to its insertion, as well as its low retrieval success rate, minimized its acceptance. It wasn't until 2002 when Taylor and McDougall revisited the concept of magnetic retrieval of the ureteral stent. Since then, few teams have published their experience with magnetic-end DJUS.
The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop. Explanation of the retrieval method and its potential complications are given to the parents, and informed consent obtained prior to surgery. All of the stents are inserted under GA in the exact same manner as regular DJUS: antegrade, retrograde (cystoscopy insertion) or open surgery. The stent's length varies between 12 and 24 cm depending on the age and weight of the child. An abdominal plain X-Ray is routinely done after pyeloplasty to check the position of the DJUS distal loop (MEDJUS or not) in the bladder before waking up the child. A successful stent insertion is defined as having a good position of the distal end and its magnet in the bladder
To remove the magnetic-end Double-J ureteral stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip, lubricated with 2% lidocaine jelly, is inserted into the urethra by the surgeon with the patient breathing inhaled premixed nitrous oxide and oxygen for procedural sedation in the outpatient clinic. Both indwelling magnets connect and the catheter can be removed together with the MEDJUS. Success of magnetic retrieval are regarded as MEDJUS retrieval in outpatient clinic with no need of general anesthesia.
The aim is to demonstrate the feasibility and safety of the magnetic-end DJUS in children and perform a medico-economic study / cost-effectiveness study to evaluate the impact of the use of MEDJUS in children in terms of retrieval time and cost, as well as OR and staff occupancy.
- Conditions
- Uropathy, Kidney Transplantation
- Being tested
- magnetic-end Double-J ureteral stent
- Keywords
- Double-J ureteral stent (DJUS), magnetic-end, Pediatric urology, Uropathy, Kidney graft
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic-end Double-J ureteral stentDevice
Also called No applied
- Inserting the ureteral stent with magnet (same process as classic ureteral stent)
- Removing the ureteral stent with magnet without general anaesthesia. Usually, the classic ureteral stent removed during a general anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Double-J ureteral stent | Experimental | Pediatric patient with an uropathy or kidney graft need the insertion of Double-J ureteral stent in a routine care Receives: Device: magnetic-end Double-J ureteral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful removal of the Double-J ureteral stent with magnet
A successful removal is a removal of the Double-J (JJ) ureteral stent with the magnet removal system, without general anaesthesia - The measure is a binary criterion: success/ failure, evaluated by the surgeon
Measured: During the stent removal consultation, usually between 8 and 30 days after the surgery
Secondary outcomes (6)
Successful insertion of the Double-J ureteral stent with magnet
A successful insertion is an insertion of the JJ ureteral stent with magnet in retrograde, antegrade process or open surgery - The measure is a binary criterion: success/ failure, evaluated by the surgeon
Measured: 1 day
Duration of hospitalization
Number of total days of hospitalization
Measured: At the end of the initial hospitalisation, at maximum 60 days
Costs of hospitalization after surgery
Costs of hospitalization after surgery
Measured: Until the stent removal consultation, usually between 8 and 30 days after the surgery
Pain score
EVA or EVENDOL pain assessment on the child's age prior to, during, and subsequent to the removal
Measured: At the end of the stent removal
Anxiety score
Anxiety assessment using the mYPAS scale (modified-Yale Preoperative Anxiety Scale) consisting of 27 items divided into 5 categories: Activity, Vocalizations, Emotional Expressivity, State of Arousal and Use of Parent.- higher score indicating higher anxiety
Measured: At the end of the stent removal
Satisfaction survey of parents
A satisfaction survey that parents completed on D7 and at the end of the stent removal
Measured: at the end of the stent removal and day 7 after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start9 Dec 2021
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UropathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Thomas BLANC, MD, PhD, Principal investigator, Assistance Publique -Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384939
- Sponsor's protocol ID
- APHP180426
- Other IDs
- 2018-A0295550
- Acronym
- EFUJA
- Status last verified
- Sep 2025
- First submitted
- 20 Feb 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Medico-economic Study of Magnetic-end Double-J Ureteral Stent Use in Children
- ClinicalTrials.gov ID
- NCT04384939
- Acronym / sponsor ID
- EFUJA / APHP180426
- Conditions
- Uropathy, Kidney Transplantation
- Keywords
- Double-J ureteral stent (DJUS), magnetic-end, Pediatric urology, Uropathy, Kidney graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 12 May 2020 (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.
Double-J ureteral stent (DJUS) is one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.
Classically, DJUS are introduced and removed in the operation room, under general anesthesia, using a cystoscope.
The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop.
To remove the magnetic stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip is inserted into the urethra in the outpatient clinic.
The purpose of this study is to demonstrate the feasibility and safety of magnetic-end Double-J ureteral stent use in children and to perform a medico-economic study.
Detailed description
First reported in 1967, ureteral stenting evolved fast until the introduction of the double-J ureteral stent (DJUS) in 1978. It has since become one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.
Many modifications have been introduced to Finney's double-J to reduce stent-related complications and disadvantages, one of which is its removal technique. Classically, DJUS are introduced and removed in the operation room (OR), under general anesthesia (GA), using a cystoscope. Efforts have been made to avoid the second procedure under GA. Preventing the patient from undergoing a second OR experience is not the only issue. For institutions, DJUS removal is time consuming and costly in terms of resources, OR occupancy, and staff. In children, the potential neurotoxicity of repeated exposures to GA, is also a major concern.
Alternatives to surgical removal of DJUS vary from basic solutions such as transurethral string, hook, or other tools, to more complex innovations such as the single use flexible cystoscope, and biodegradable stents. Moreover, some pediatric teams used the externalized pyeloureteral stent as an alternative to DJUS. Using magnet for ureteral stent retrieval was introduced in the early 80s. Difficulties related to its insertion, as well as its low retrieval success rate, minimized its acceptance. It wasn't until 2002 when Taylor and McDougall revisited the concept of magnetic retrieval of the ureteral stent. Since then, few teams have published their experience with magnetic-end DJUS.
The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop. Explanation of the retrieval method and its potential complications are given to the parents, and informed consent obtained prior to surgery. All of the stents are inserted under GA in the exact same manner as regular DJUS: antegrade, retrograde (cystoscopy insertion) or open surgery. The stent's length varies between 12 and 24 cm depending on the age and weight of the child. An abdominal plain X-Ray is routinely done after pyeloplasty to check the position of the DJUS distal loop (MEDJUS or not) in the bladder before waking up the child. A successful stent insertion is defined as having a good position of the distal end and its magnet in the bladder
To remove the magnetic-end Double-J ureteral stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip, lubricated with 2% lidocaine jelly, is inserted into the urethra by the surgeon with the patient breathing inhaled premixed nitrous oxide and oxygen for procedural sedation in the outpatient clinic. Both indwelling magnets connect and the catheter can be removed together with the MEDJUS. Success of magnetic retrieval are regarded as MEDJUS retrieval in outpatient clinic with no need of general anesthesia.
The aim is to demonstrate the feasibility and safety of the magnetic-end DJUS in children and perform a medico-economic study / cost-effectiveness study to evaluate the impact of the use of MEDJUS in children in terms of retrieval time and cost, as well as OR and staff occupancy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double-J ureteral stent | Experimental | Device: magnetic-end Double-J ureteral stentPediatric patient with an uropathy or kidney graft need the insertion of Double-J ureteral stent in a routine care |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child aged between 0 and 17 years and 10 months at the surgery
- Child operated at the Necker hospital for an uropathy or kidney graft need the insertion of JJ ureteral stent
- Parents or legal guardians signed the Informed consent form
- Social insurance affiliation
Key exclusion criteria (4 listed)
- All clinical situation need an MRI
- Contraindication with the experimental medical device (severe infections, obstruction, …)
- For the medico-economic study, a comparative group will be constituted with patients treated with classic ureteral stent in the Necker hospital in the previous years.
- This group will be matched with age (<5 years, 5-12 years and >13years), sex and surgery indication (kidney graft or other).
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-end Double-J ureteral stentAlso: No applied* Inserting the ureteral stent with magnet (same process as classic ureteral stent) * Removing the ureteral stent with magnet without general anaesthesia. Usually, the classic ureteral stent removed during a general anaesthesia. | Device | Double-J ureteral stent |
Primary outcome
Successful removal of the Double-J ureteral stent with magnet
Time frame: During the stent removal consultation, usually between 8 and 30 days after the surgery
A successful removal is a removal of the Double-J (JJ) ureteral stent with the magnet removal system, without general anaesthesia - The measure is a binary criterion: success/ failure, evaluated by the surgeon
6 secondary outcomes
Successful insertion of the Double-J ureteral stent with magnet
Time frame: 1 day
Duration of hospitalization
Time frame: At the end of the initial hospitalisation, at maximum 60 days
Costs of hospitalization after surgery
Time frame: Until the stent removal consultation, usually between 8 and 30 days after the surgery
Pain score
Time frame: At the end of the stent removal
Anxiety score
Time frame: At the end of the stent removal
Satisfaction survey of parents
Time frame: at the end of the stent removal and day 7 after
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 20 Nov 2025.
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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.
Thomas BLANC, MD, PhD principal investigator
Assistance Publique -Hôpitaux de Paris (AP-HP)
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-end Double-J ureteral stent in people with Uropathy and Kidney Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 4 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 20 Nov 2025. 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 France. 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?
Successful removal of the Double-J ureteral stent with magnet (time frame: During the stent removal consultation, usually between 8 and 30 days after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.