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RecruitingNCT07247617Updated Nov 25, 2025

Flexible vs Semi-rigid URS

An interventional study of Flexible URS and Semi-Rigid URS in Ureteric Stone, Flexible Ureteroscopy and Upper Urinary Tract Stones, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.

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

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To compare the efficacy, safety, success rate, operative time, and cost-effectiveness of flexible ureteroscopy versus semirigid ureteroscopy in the management of upper ureteric stones smaller than 2 cm.

The investigators' main concern in this study is Upper third ureteric stones to determine which cases can be treated with Semi-Rigid Ureteroscopy, and which one needs flexible ureteroscopy. This depends on several factors:

  1. Division of the upper third of the ureter
  2. Stone size
  3. Stone impaction
  4. Surgeon experience
  5. Anesthesia
  6. Ureteric dilatation above the stone
  7. Mini endoscopy
Read the detailed description

Ureteroscopy (URS) is a widely accepted minimally invasive approach for treating ureteric stones, particularly proximal (upper) ureteral stones. Options include rigid, semirigid (often grouped as one), and flexible ureteroscopes. Flexible ureteroscopy allows deflection and access to the proximal ureter and intrarenal collecting system, facilitating treatment of stones that are difficult to reach with rigid ureteroscopes due to anatomical constraints or stone migration. Semirigid ureteroscopy has shown good efficacy, particularly for stones amenable to direct access without complex deflection, offering shorter operative times and lower costs. Studies report stone-free rates of approximately 90-93% for flexible URS and 81-90% for semirigid URS, with flexible URS having somewhat higher success in accessing stones and managing fragment migration. However, flexible URS typically incurs higher costs and longer operative times. Semirigid ureteroscopy is often the initial approach for upper ureteric stones where anatomy, stone size (\<2 cm), and location allow straightforward access.

  • Flexible ureteroscopy is preferred when stones are located higher in the ureter, difficult to reach by semirigid scopes, or if stone migration into the kidney occurs. It is also favored when more maneuverability is required to treat complex anatomy or large stones.
  • Both modalities use holmium laser lithotripsy for stone fragmentation.
  • Treatment choice also depends on surgeon preference, availability of equipment, and cost considerations.

Despite advances, there is ongoing debate about the optimal first-line ureteroscopic approach for upper ureteric stones, balancing efficacy, safety, cost, and procedure time. Comparing flexible and rigid/semirigid ureteroscopy outcomes informs treatment algorithms, improving patient care and resource utilization, especially in differing healthcare settings.

02

Conditions studied

  • Ureteric Stone
  • Flexible Ureteroscopy
  • Upper Urinary Tract Stones
03

In context

Ureterolithiasis

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

This study's planned enrollment of 100 is close to 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 and older
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

  • Patients ≥18 years
  • upper ureteric stone
  • ≤20 mm

Exclusion criteria

Exclusion Criteria:

  • Associated renal stones
  • Any to Anesthesia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

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

Study arms

  • Active comparator
    Flexible Ureteroscopy

    Procedure: Flexible URS

  • Experimental
    Semi-Rigid Ureteroscopy

    Procedure: Semi-Rigid URS

Interventions

  • ProcedureFlexible URS

    Flexible URS

  • ProcedureSemi-Rigid URS

    Semi-Rigid URS

06

What researchers measure

Primary outcomes

  1. - Stone-free rate at 3 months duration

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Assiut Hospital
    Asyut, Asyut Governorate, Egypt
    Recruiting
08

References and documents

Publications

  • Wright AE, Rukin NJ, Somani BK. Ureteroscopy and stones: Current status and future expectations. World J Nephrol. 2014 Nov 6;3(4):243-8. doi: 10.5527/wjn.v3.i4.243. PubMed 25374818 ↗

Individual participant data

Plan to share: Undecided

09

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

Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 12 months after the start.

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 planned 12 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
Sep 22, 2025
First posted
Nov 25, 2025
StartActual
Oct 1, 2025
Primary completionEst.
Oct 1, 2026
CompletionEst.
Jan 1, 2027
Last update
Nov 25, 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 Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07247617
Lead sponsor
Assiut University
Responsible party
Omar Ahmed Hamada Ali (Urology Resident, Assiut University) — Principal investigator
First posted
Nov 25, 2025
Start date
Oct 1, 2025
Primary completion
Oct 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Nov 25, 2025

Study contacts

Omar Ahmed Hamada Ali
Contact
omarahmedhamada74@gmail.com
+201092868286
Mohamed Ragab Abdallah, Doctor
Contact
mohammedurology1290@gmail.com
+201066237580

Oversight

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

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