Feasibility of Magnetic-end Double-J Ureteral Stent Use in Children

NCT04384939 | Completed

• 2 other identifiers: APHP1804262018-A0295550
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Uropathy; Kidney Transplantation

Keywords

Double-J ureteral stent (DJUS); magnetic-end; Pediatric urology; Uropathy; Kidney graft

Outcome Measures

Primary Outcomes (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

  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

  1 day

• Duration of hospitalization

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

• Costs of hospitalization after surgery

  Until the stent removal consultation, usually between 8 and 30 days after the surgery

• Pain score

  At the end of the stent removal

• Anxiety score

  At the end of the stent removal

Study Arms (1)

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

Device: magnetic-end Double-J ureteral stent

Interventions

magnetic-end Double-J ureteral stent DEVICE

* 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.

Also known as: No applied

Double-J ureteral stent

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker

Paris, 75015, France

Location

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Thomas BLANC, MD, PhD

  Assistance Publique -Hôpitaux de Paris (AP-HP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: May 12, 2020
• Study Start: December 9, 2021
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: November 20, 2025

Record last verified: 2025-09

Locations

FR (1)