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CompletedNCT03404986Updated Dec 5, 2022

Ultrasound Guided Ureteroscopy and Ureteric Stones

An interventional study of ureteroscopy and Ultrasonography in Ureteric Stone, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-05.

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

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11 people in the United States. The prevalence of calculi in Afro-Asian region including Arab Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for definitive management of ureteric stones. Conventional ureteroscopy relies on intraoperative fluoroscopy for visualization and guidance, exposing the patient, surgeon and operating room staff to ionizing radiation. To minimize the hazards of ionizing radiation there has been a trend toward radiation free alternative imaging modalities . Ultrasound provides an excellent alternative for upper urinary tract imaging because it is radiation free, rapid, portable and allows excellent visualization of the renal pelvis and calyces. There is increasing awareness and concern about the clinical use of ionizing radiation and the need to decrease exposure of patients and medical professionals. Ultrasound guided ureteroscopy in pregnant females and children- in whom fluoroscopy is to be minimized or avoided when possible - has been reported.

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 80 is below the median of 101 across 66 interventional studies indexed under Ureterolithiasis.

Browse Ureterolithiasis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
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

  1. Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
  2. Age group 18 years old or above.
  3. Stone size 15 mm or less.

Exclusion criteria

Exclusion Criteria:

  1. Patients with bilateral ureteric stones
  2. Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
  3. Previously failed ureteroscopy or previous ureteroneocystostomy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Other
    Standardized ureteroscopy group

    Procedure: ureteroscopy

  • Other
    Ultrasonography ureteroscopy group

    Procedure: ureteroscopy · Radiation: Ultrasonography

Interventions

  • Procedureureteroscopy

    The patients will be subjected to rigid ureteroscopy

  • RadiationUltrasonography

    The patients will be subjected to Ultrasonography

06

What researchers measure

Primary outcomes

  1. Number of patients treated effectively by the two methods

    Time frame: 1 hour

07

Study locations

1 site
  • Women Health Hospital - Assiut university
    Assiut, 71111, 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 Apr 2018 to primary completion in Apr 2020, 24 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 24 months is above 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
Jan 14, 2018
First posted
Jan 19, 2018
StartActual
Apr 1, 2018
Primary completionActual
Apr 1, 2020
CompletionActual
Apr 1, 2020
Last update
Dec 5, 2022
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 Dec 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03404986
Lead sponsor
Assiut University
Responsible party
Mohamed Loay (Resident, Assiut University) — Principal investigator
First posted
Jan 19, 2018
Start date
Apr 1, 2018
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020
Last update
Dec 5, 2022

Oversight

Data monitoring committee
No
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 2022. You cannot join it, but the record below documents what was studied.

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