Kidney StoneNCT07238803
Outcomes of Using FANS With FURS in TTT of Lower Calyceal Stones.
A study testing flexible and navigable suction sheath with flexible ureteroscopy in people with Kidney Stone and Kidney Calculi, run by Zagazig University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and assess the outcomes of flexible ureteroscopy (FURS) with flexible and navigable suction UAS (FANS) in the treatment of lower calyceal stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Kidney Calculi
- What is being tested?
- flexible and navigable suction sheath with flexible ureteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Feb 2026
- 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
- Adult patients ≥ 18 years old.
- Patients with lower calyceal stones scheduled for FURS.
Who cannot join
- patients with active urinary tract infections.
- Patients with renal and ureteric anomalies.
- patients with coagulopathy
- patients who are refusing to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University Hospitals
Zagazig, 44511
safaa abdelmoez elnaggar, professor, +20 122 371 9011, safaa_elnaggar@hotmail.com
About this study
Official title: Outcomes of Using Flexible and Navigable Suction Sheath With Flexible Ureteroscopy in Treatment of Lower Calyceal Stones: A Prospective Study
The aim of this study is to evaluate and assess the outcomes of flexible ureteroscopy (FURS) with flexible and navigable suction UAS (FANS) in the treatment of lower calyceal stones.
Read the detailed description
With the continued advancements of technology and increasing experience gained by urologists in ureteroscopic skills, fURS has become a standard treatment for kidney stones lesser than 2 cm in diameter. In the previous the European guidelines and American Urologic Association guidelines for management of urolithiasis, fURS were recommended as a second-line treatment for stones less than 2 cm after ESWL, however in the recent revision of the guidelines, RIRS can be used as the first-line management option especially for stones measuring between 11 and 20 mm.
The ureteral access sheath (UAS), initially introduced by Hisao Takayasu in 1974 Despite continued advances in retrograde intrarenal surgery (RIRS), recent real-world data for 6669 patients in the FLEXOR registry revealed residual fragments in 21.7% of patients, of whom 51.5% required a second intervention.
The sepsis rate in the same study was just 1.3%. Hence, there is still much to improve in terms of technical expertise and technology for RIRS. Many aids have been introduced to streamline RIRS and improve procedural success. These include suction via a scope or ureteral access sheath (UAS), postintervention catheters, slimmer single-use scopes, and high-power lasers, these improvements have made RIRS a standard of care according to international guidelines.
It has been reported that vacuum aided or suction aspiration sheaths have strong potential to improve the stone-free status (SFS) rate and minimize infectious compilations associated with the negative effects of high intrarenal pressure and temperature, However, the true potential of the advances for RIRS has yet to be investigated. The ideal game-changing technological innovation for RIRS should improve all key outcomes of the procedure, including the rate of immediate single stage SFS, perioperative and postoperative complications, and the reintervention rate for residual fragments. One recent advance that has shown much promise is a flexible and navigable sheath (FANS) So, we will conduct a prospective study to assess whether FANS could be a potential game-changer for RIRS in adults with lower calyceal stones instead of traditional UAS especially regarding stone-free rates (SFR), complications and cost.
- Conditions
- Kidney Stone, Kidney Calculi
- Being tested
- flexible and navigable suction sheath with flexible ureteroscopy
- Keywords
- Flexible Ureteroscopy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible and navigable suction sheath with flexible ureteroscopyDevice
Also called FANS ureteral access sheath
placement of flexible and navigable suction sheath (FANS)which has an oblique side branch with pressure vent, that can be connected to negative pressure aspiration, and a flexible tip, allowing for efficient and effective treatment of urinary stones.
- Flexible URS diameter will be at the least 2 Fr smaller than the sheath.
- The main tube is closed by a rubber seal with a center aperture as the flexible ureteroscope pathway, The oblique tube with a pressure-regulating venting slit along the longitudinal axis acts as a suctioning channel connected to a vacuum device.
- The inflow of irrigation is through the endoscope, the outflow of irrigation is between the scope and the sheath.
- A vortex is created at the distal end of the sheath, the irrigation fluid, the stone fragments, dust, and blood, etc. in the vortex can be aspirated out.
- The aspiration pressure can be adjusted by the pressure vent on the oblique side branch of the sheath.
| Study group | Role | What they receive |
|---|---|---|
| main arm .. single arm | Experimental | Patients with lower calyceal stones Receives: Device: flexible and navigable suction sheath with flexible ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Stone-Free Rate Following Flexible Ureteroscopy with FANS sheath for Management of Renal and Ureteral Calculi.
This clinical study aims to evaluate the stone-free rate (SFR) following flexible ureteroscopy (FURS) in patients with renal or ureteral calculi. The primary outcome measure is the proportion of patients who achieve complete stone clearance, as determined by postoperative imaging (non-contrast CT or ultrasound) within a defined follow-up period.
Measured: 1 month after the procedure (preferred and most common for SFR assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mahmoud Ahmed Elsayed Ahmed Lasheen, Zagazig University
- Investigators
- Abdul Latif Mohammed Zayed, professor of urology, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238803
- Sponsor's protocol ID
- 853
- Status last verified
- Jan 2025
- First submitted
- 13 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available upon reasonable request from qualified researchers after study completion. A data dictionary will also be provided. Time Frame: 6 months after final publication, available for 3 years. Access Criteria: Contact the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Using Flexible and Navigable Suction Sheath With Flexible Ureteroscopy in Treatment of Lower Calyceal Stones: A Prospective Study
- ClinicalTrials.gov ID
- NCT07238803
- Acronym / sponsor ID
- 853
- Conditions
- Kidney Stone, Kidney Calculi
- Keywords
- Flexible Ureteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 20 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.
The aim of this study is to evaluate and assess the outcomes of flexible ureteroscopy (FURS) with flexible and navigable suction UAS (FANS) in the treatment of lower calyceal stones.
Detailed description
With the continued advancements of technology and increasing experience gained by urologists in ureteroscopic skills, fURS has become a standard treatment for kidney stones lesser than 2 cm in diameter. In the previous the European guidelines and American Urologic Association guidelines for management of urolithiasis, fURS were recommended as a second-line treatment for stones less than 2 cm after ESWL, however in the recent revision of the guidelines, RIRS can be used as the first-line management option especially for stones measuring between 11 and 20 mm.
The ureteral access sheath (UAS), initially introduced by Hisao Takayasu in 1974 Despite continued advances in retrograde intrarenal surgery (RIRS), recent real-world data for 6669 patients in the FLEXOR registry revealed residual fragments in 21.7% of patients, of whom 51.5% required a second intervention.
The sepsis rate in the same study was just 1.3%. Hence, there is still much to improve in terms of technical expertise and technology for RIRS. Many aids have been introduced to streamline RIRS and improve procedural success. These include suction via a scope or ureteral access sheath (UAS), postintervention catheters, slimmer single-use scopes, and high-power lasers, these improvements have made RIRS a standard of care according to international guidelines.
It has been reported that vacuum aided or suction aspiration sheaths have strong potential to improve the stone-free status (SFS) rate and minimize infectious compilations associated with the negative effects of high intrarenal pressure and temperature, However, the true potential of the advances for RIRS has yet to be investigated. The ideal game-changing technological innovation for RIRS should improve all key outcomes of the procedure, including the rate of immediate single stage SFS, perioperative and postoperative complications, and the reintervention rate for residual fragments. One recent advance that has shown much promise is a flexible and navigable sheath (FANS) So, we will conduct a prospective study to assess whether FANS could be a potential game-changer for RIRS in adults with lower calyceal stones instead of traditional UAS especially regarding stone-free rates (SFR), complications and cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| main arm .. single arm | Experimental | Device: flexible and navigable suction sheath with flexible ureteroscopyPatients with lower calyceal stones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients ≥ 18 years old.
- Patients with lower calyceal stones scheduled for FURS.
Key exclusion criteria (4 listed)
- patients with active urinary tract infections.
- Patients with renal and ureteric anomalies.
- patients with coagulopathy
- patients who are refusing to participate.
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 and navigable suction sheath with flexible ureteroscopyAlso: FANS ureteral access sheathplacement of flexible and navigable suction sheath (FANS)which has an oblique side branch with pressure vent, that can be connected to negative pressure aspiration, and a flexible tip, allowing for efficient and effective treatment of urinary stones. * Flexible URS diameter will be at the least 2 Fr smaller than the sheath. * The main tube is closed by a rubber seal with a center aperture as the flexible ureteroscope pathway, The oblique tube with a pressure-regulating venting slit along the longitudinal axis acts as a suctioning channel connected to a vacuum device. * The inflow of irrigation is through the endoscope, the outflow of irrigation is between the scope and the sheath. * A vortex is created at the distal end of the sheath, the irrigation fluid, the stone fragments, dust, and blood, etc. in the vortex can be aspirated out. * The aspiration pressure can be adjusted by the pressure vent on the oblique side branch of the sheath. | Device | main arm .. single arm |
Primary outcome
Evaluation of Stone-Free Rate Following Flexible Ureteroscopy with FANS sheath for Management of Renal and Ureteral Calculi.
Time frame: 1 month after the procedure (preferred and most common for SFR assessment)
This clinical study aims to evaluate the stone-free rate (SFR) following flexible ureteroscopy (FURS) in patients with renal or ureteral calculi. The primary outcome measure is the proportion of patients who achieve complete stone clearance, as determined by postoperative imaging (non-contrast CT or ultrasound) within a defined follow-up period.
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 20 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available upon reasonable request from qualified researchers after study completion. A data dictionary will also be provided. Time Frame: 6 months after final publication, available for 3 years. Access Criteria: Contact the principal investigator.
Related trials for Kidney Stone
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Automated Versus Manual Irrigation During Flexible Ureteroscopy
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Optimal Intrarenal Pressure During Flexible Ureteroscopy
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
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Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
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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.
Abdul Latif Mohammed Zayed, professor of urology study director
Zagazig University
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 and navigable suction sheath with flexible ureteroscopy in people with Kidney Stone and Kidney Calculi, run by Zagazig 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 2 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: looking for participants now, as of the sponsor's last update on 20 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 Mahmoud Ahmed Lasheen, Resident (+201069524468, ma.ahmed24@fakmed.zu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Stone-Free Rate Following Flexible Ureteroscopy with FANS sheath for Management of Renal and Ureteral Calculi. (time frame: 1 month after the procedure (preferred and most common for SFR assessment)). 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 20 Nov 2025.