Renal Stone DiseaseNCT07904676
Flexible Ureteroscopy With Novel Flexible Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3cm Lower Calyceal Renal Stones
A study testing Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath and Mini-Percutaneous Nephrolithotomy in people with Renal Stone Disease and Renal Stones, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to compare the efficacy, safety, and patient outcomes of flexible ureteroscopy with a novel flexible ureteral access sheath and mini-percutaneous nephrolithotomy in the treatment of 2-3 cm lower calyceal renal stones. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Stone Disease, Renal Stones, Flexible Ureteroscopy
- What is being tested?
- Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath and Mini-Percutaneous Nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Lower Calyceal renal stones measuring 2-3 cm in diameter confirmed by CT scan
- Candidates suitable for either flexible ureteroscopy with flexible ureteral access sheath or mini-percutaneous nephrolithotomy based on stone characteristics and patient anatomy.
Who cannot join
- Severe coagulopathy or bleeding disorders
- Active urinary tract infection
- Pregnancy
- Significant renal anatomical abnormalities complicating access
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the efficacy, safety, and patient outcomes of flexible ureteroscopy with a novel flexible ureteral access sheath and mini-percutaneous nephrolithotomy in the treatment of 2-3 cm lower calyceal renal stones.
- Conditions
- Renal Stone Disease, Renal Stones, Flexible Ureteroscopy, Mini Percutaneous Nephrolithotomy
- Being tested
- Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath, Mini-Percutaneous Nephrolithotomy
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Ureteroscopy with Novel Flexible Ureteral Access SheathProcedure or surgery
A novel flexible ureteral access sheath is placed through the ureter. Flexible ureteroscope is advanced through the sheath to the kidney. Holmium laser lithotripsy is used to fragment and remove the stone. Postoperative ureteral stent may be placed if required.
Mini-Percutaneous NephrolithotomyProcedure or surgery
Percutaneous access to the kidney is obtained under fluoroscopic guidance. Tract dilation is performed, and a mini-nephroscope is introduced through 20 Fr access sheath. Stone is fragmented and removed using pneumatic or ultrasonic lithotripsy. Postoperative nephrostomy tube or stent may be placed as per surgeon's judgment.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath | Active comparator | Not described Receives: Procedure: Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath |
| Mini-Percutaneous Nephrolithotomy | Active comparator | Not described Receives: Procedure: Mini-Percutaneous Nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate
It is defined as no residual stone fragments larger than 3 mm confirmed by imaging.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Aug 2024
- Primary completion1 Aug 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Stone DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904676
- Sponsor's protocol ID
- FMASU MD283/2024
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopy With Novel Flexible Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3cm Lower Calyceal Renal Stones
- ClinicalTrials.gov ID
- NCT07904676
- Acronym / sponsor ID
- FMASU MD283/2024
- Conditions
- Renal Stone Disease, Renal Stones, Flexible Ureteroscopy, Mini Percutaneous Nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 29 Oct 2026 (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.
The aim of the study is to compare the efficacy, safety, and patient outcomes of flexible ureteroscopy with a novel flexible ureteral access sheath and mini-percutaneous nephrolithotomy in the treatment of 2-3 cm lower calyceal renal stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath | Active comparator | Procedure: Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath |
| Mini-Percutaneous Nephrolithotomy | Active comparator | Procedure: Mini-Percutaneous Nephrolithotomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65 years
- Lower Calyceal renal stones measuring 2-3 cm in diameter confirmed by CT scan
- Candidates suitable for either flexible ureteroscopy with flexible ureteral access sheath or mini-percutaneous nephrolithotomy based on stone characteristics and patient anatomy.
Key exclusion criteria (4 listed)
- Severe coagulopathy or bleeding disorders
- Active urinary tract infection
- Pregnancy
- Significant renal anatomical abnormalities complicating access
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 Ureteroscopy with Novel Flexible Ureteral Access SheathA novel flexible ureteral access sheath is placed through the ureter. Flexible ureteroscope is advanced through the sheath to the kidney. Holmium laser lithotripsy is used to fragment and remove the stone. Postoperative ureteral stent may be placed if required. | Procedure or surgery | Flexible Ureteroscopy with Novel Flexible Ureteral Access Sheath |
| Mini-Percutaneous NephrolithotomyPercutaneous access to the kidney is obtained under fluoroscopic guidance. Tract dilation is performed, and a mini-nephroscope is introduced through 20 Fr access sheath. Stone is fragmented and removed using pneumatic or ultrasonic lithotripsy. Postoperative nephrostomy tube or stent may be placed as per surgeon's judgment. | Procedure or surgery | Mini-Percutaneous Nephrolithotomy |
Primary outcome
Stone-free rate
Time frame: two weeks
It is defined as no residual stone fragments larger than 3 mm confirmed by imaging.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ureteroscopy with Novel Flexible Ureteral Access Sheath and Mini-Percutaneous Nephrolithotomy in people with Renal Stone Disease and Renal Stones, run by Ain Shams 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 4 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: finished, as of the sponsor's last update on 29 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.