ClinicalTrials.gg
CompletedNCT06761378Updated Jan 7, 2025

Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease

An interventional study of Renal stent and Flexible uretroscopy in Ureteric Stone, sponsored by Menoufia University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Menoufia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jan 2024, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study summary

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished : fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

Read the detailed description

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

02

Conditions studied

  • Ureteric Stone

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03

In context

Ureterolithiasis

84 studies on the registry are indexed under Ureterolithiasis; 19 are open to participants now.

This study's enrollment of 60 is below the median of 101 across 66 interventional studies indexed under Ureterolithiasis.

Browse Ureterolithiasis studies →

Lead sponsor

Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients with stone kidney up to 2 cm
  • failed ESWL (extracorporeal shock wave lithotripsy)
  • difficult PCNL (percutaneous nephrolithotomy)

Exclusion criteria

Exclusion Criteria:

  • Size more than 2 cm
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    2 weeks Dj insertion

    Renal stent for 2 weeks prior flexible uretroscopy

    Procedure: Renal stent · Device: Flexible uretroscopy

  • Active comparator
    4weeks Dj insertion

    Renal stent for 4 weeks prior flexible uretroscopy

    Procedure: Renal stent · Device: Flexible uretroscopy

Interventions

  • ProcedureRenal stent

    Renal stent before flexible uretroscopy

  • DeviceFlexible uretroscopy

    Renal stent for 2 weeks prior flexible uretroscopy

06

What researchers measure

Primary outcomes

  1. passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks

    Patients will classified in two groups, one will insert DJ for two weeks and the other insert DJ for four weeks then remove it and trial to insert access sheath for flexible uretroscopy duriing passage of the sheath the ureteric dilitation will be assessed if the sheath pass or not measure so , the ability of the ureteric dilitation to obtain the sheath is it dilated enough after 2 or 4 weeks

    Time frame: 6 months

07

Study locations

1 site
  • Menofia university
    Cairo, State Or Province 32511, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2024 to primary completion in Dec 2024, 11 months.

Of 36 non-industry interventional studies with no phase under Ureterolithiasis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 11 months is below that.

Counting every sponsor, half of 38 studies reached it within 20 months; a quarter within 11 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2024
First posted
Jan 7, 2025
StartActual
Jan 1, 2024
Primary completionActual
Dec 1, 2024
CompletionActual
Dec 4, 2024
Last update
Jan 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06761378
Responsible party
Hossam Kandeel (Assistant lecturer of urology, Menoufia University) — Principal investigator
First posted
Jan 7, 2025
Start date
Jan 1, 2024
Primary completion
Dec 1, 2024
Completion
Dec 4, 2024
Last update
Jan 7, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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