Ureteric StoneNCT07247617
Flexible vs Semi-rigid URS
A study testing Flexible URS and Semi-Rigid URS in people with Ureteric Stone and Flexible Ureteroscopy, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteric Stone, Flexible Ureteroscopy, Upper Urinary Tract Stones
- What is being tested?
- Flexible URS and Semi-Rigid URS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years
- upper ureteric stone
- ≤20 mm
Who cannot join
- Associated renal stones
- Any contraindications to Anesthesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy in Upper Third Ureteric Stones Management: a Prospective Randomized Trial
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:
- Division of the upper third of the ureter
- Stone size
- Stone impaction
- Surgeon experience
- Anesthesia
- Ureteric dilatation above the stone
- 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.
- Being tested
- Flexible URS, Semi-Rigid URS
- Medical subject headings
- Ureterolithiasis, Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible URSProcedure or surgery
Flexible URS
Semi-Rigid URSProcedure or surgery
Semi-Rigid URS
| Study group | Role | What they receive |
|---|---|---|
| Flexible Ureteroscopy | Active comparator | Not described Receives: Procedure: Flexible URS |
| Semi-Rigid Ureteroscopy | Experimental | Not described Receives: Procedure: Semi-Rigid URS |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Stone-free rate at 3 months duration
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ureteric StoneStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ahmed Hamada Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247617
- Sponsor's protocol ID
- Upper third ureteric stones
- Status last verified
- Oct 2025
- First submitted
- 22 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-rigid Ureteroscopy Versus Flexible Ureteroscopy in Upper Third Ureteric Stones Management: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07247617
- Acronym / sponsor ID
- Upper third ureteric stones
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Division of the upper third of the ureter
- Stone size
- Stone impaction
- Surgeon experience
- Anesthesia
- Ureteric dilatation above the stone
- Mini endoscopy
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Ureteroscopy | Active comparator | Procedure: Flexible URS |
| Semi-Rigid Ureteroscopy | Experimental | Procedure: Semi-Rigid URS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥18 years
- upper ureteric stone
- ≤20 mm
Key exclusion criteria (2 listed)
- Associated renal stones
- Any contraindications to Anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible URSFlexible URS | Procedure or surgery | Flexible Ureteroscopy |
| Semi-Rigid URSSemi-Rigid URS | Procedure or surgery | Semi-Rigid Ureteroscopy |
Primary outcome
- Stone-free rate at 3 months duration
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Results publication: PubMed 25374818Wright 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible URS and Semi-Rigid URS in people with Ureteric Stone and Flexible Ureteroscopy, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Ahmed Hamada Ali (+201092868286, omarahmedhamada74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Stone-free rate at 3 months duration (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07247617, which also lists 1 linked publication.
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 25 Nov 2025.