AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

France1 site
  • Hôpital Necker

    Paris, 75015

Other trials in France

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.

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 groups in NCT04384939
Study groupRoleWhat they receive
Double-J ureteral stentExperimentalPediatric 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.

  1. 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)
  1. 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

  2. Duration of hospitalization

    Number of total days of hospitalization

    Measured: At the end of the initial hospitalisation, at maximum 60 days

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted12 May 2020
  2. Study start9 Dec 2021
  3. Primary completion29 Aug 2023
  4. Study completion29 Aug 2023

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in