NephrolithiasisNCT06889051
Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones
A study testing Flexible & Navigable Suction Ureteral Access Sheath (FANS) and Antegrade Suction via Percutaneous Nephrostomy in people with Nephrolithiasis and Urolithiasis, run by Benha University.
Trial summary
This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Urolithiasis, Endourology
- What is being tested?
- Flexible & Navigable Suction Ureteral Access Sheath (FANS) and Antegrade Suction via Percutaneous Nephrostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2025to 30 Mar 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 diagnosed with renal stones (1.5-2 cm) confirmed by non-contrast computed tomography (NCCT)
- Patients undergoing flexible ureteroscopy (FURS) as the primary treatment approach
- Patients with no active urinary tract infection (UTI) at baseline
- Patients who provide written informed consent
Who cannot join
- Patients with anatomical anomalies (e.g., horseshoe kidney, PUJ obstruction)
- Patients with a single functioning kidney
- Pregnant women
- Patients with a history of urological malignancy
- Patients with active bleeding disorders or those on anticoagulant therapy that cannot be safely discontinued
- Patients at high risk for anesthesia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Study Between Using Retrograde Flexible Ureteroscopy With Flexible & Navigable Suction Ureteral Access Sheath Versus Retrograde Flexible Ureteroscopy With Antegrade Suction in Lower Calyceal Stone: A Randomized Controlled Trial
This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible \& Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.
- Conditions
- Nephrolithiasis, Urolithiasis, Endourology
- Being tested
- Flexible & Navigable Suction Ureteral Access Sheath (FANS), Antegrade Suction via Percutaneous Nephrostomy
- Keywords
- Flexible Ureteroscopy (FURS), Ureteral Access Sheath (UAS), Suction Ureteral Access Sheath (FANS), Antegrade Suction, Percutaneous Nephrostomy (PCN), Laser Lithotripsy
- Medical subject headings
- Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible & Navigable Suction Ureteral Access Sheath (FANS)Procedure or surgery
The Flexible \& Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy using Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W).
Antegrade Suction via Percutaneous NephrostomyProcedure or surgery
This technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone fragmentation. This technique aims to improve stone clearance while minimizing ureteral trauma associated with access sheaths.
| Study group | Role | What they receive |
|---|---|---|
| Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group | Experimental | Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with the Flexible \& Navigable Suction Ureteral Access Sheath (FANS). The FANS facilitates continuous suctioning, improving stone fragment evacuation, reducing intrarenal pressure, and optimizing stone-free rates (SFR). Receives: Procedure: Flexible & Navigable Suction Ureteral Access Sheath (FANS) |
| Antegrade Suction with Flexible Ureteroscopy (FURS) Group | Active comparator | Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with antegrade suction, using a percutaneous nephrostomy (PCN) access for suctioning from the kidney during the procedure. This method aims to enhance stone fragment clearance and reduce intrarenal pressure without using a ureteral access sheath. Receives: Procedure: Antegrade Suction via Percutaneous Nephrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-Free Rate (SFR)
The stone-free rate (SFR) will be assessed one month postoperatively using non-contrast computed tomography (NCCT) to determine the presence or absence of residual stone fragments ≥4 mm. A higher SFR indicates better effectiveness of the intervention.
Measured: 1 Month Postoperative
Secondary outcomes (5)
Operative Time
The total operative time will be recorded from the initial endoscopic access to procedure completion. This includes access sheath insertion, ureteroscopy, lithotripsy, and final stone evacuation. A shorter operative time is indicative of a more efficient technique.
Measured: During Surgery
Intraoperative Bleeding Requiring Intervention
The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.
Measured: During Surgery
Ureteral Injury
The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.
Measured: During Surgery
Postoperative Hematuria
The presence of postoperative hematuria (macroscopic bleeding) will be assessed. It will be classified as mild (self-limited), moderate (requiring irrigation), or severe (requiring intervention such as transfusion or embolization).
Measured: Within 7 Days Postoperative
Postoperative Urosepsis
The incidence of postoperative urosepsis, defined as systemic inflammatory response syndrome (SIRS) with a positive urine culture and clinical deterioration requiring IV antibiotics or ICU admission, will be recorded.
Measured: Within 7 Days Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Benha 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
- Model description
- This is a randomized controlled trial comparing two different suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones. Participants will be assigned to one of two groups: * Group A (Intervention Group) - flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) * Group B (Control Group) - flexible ureteroscopy (FURS) with Antegrade Suction via percutaneous nephrostomy. The study will assess stone-free rates (SFR), operative time, and complications.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abd El-Wahab Diab, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889051
- Sponsor's protocol ID
- MD-290-2025
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including baseline characteristics, intraoperative details, postoperative outcomes, and complication data for research purposes. No personally identifiable information will be disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study Between Using Retrograde Flexible Ureteroscopy With Flexible & Navigable Suction Ureteral Access Sheath Versus Retrograde Flexible Ureteroscopy With Antegrade Suction in Lower Calyceal Stone: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06889051
- Acronym / sponsor ID
- MD-290-2025
- Conditions
- Nephrolithiasis, Urolithiasis, Endourology
- Keywords
- Flexible Ureteroscopy (FURS), Ureteral Access Sheath (UAS), Suction Ureteral Access Sheath (FANS), Antegrade Suction, Percutaneous Nephrostomy (PCN), Laser Lithotripsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 21 Mar 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.
This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible \& Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial comparing two different suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones. Participants will be assigned to one of two groups: * Group A (Intervention Group) - flexible ureteroscopy (FURS) with Flexible \& Navigable Suction Ureteral Access Sheath (FANS) * Group B (Control Group) - flexible ureteroscopy (FURS) with Antegrade Suction via percutaneous nephrostomy. The study will assess stone-free rates (SFR), operative time, and complications.
| Arm | Type | Receives |
|---|---|---|
| Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group | Experimental | Procedure: Flexible & Navigable Suction Ureteral Access Sheath (FANS)Patients in this group will undergo retrograde flexible ureteroscopy (FURS) with the Flexible \& Navigable Suction Ureteral Access Sheath (FANS). The FANS facilitates continuous suctioning, improving stone fragment evacuation, reducing intrarenal pressure, and optimizing stone-free rates (SFR). |
| Antegrade Suction with Flexible Ureteroscopy (FURS) Group | Active comparator | Procedure: Antegrade Suction via Percutaneous NephrostomyPatients in this group will undergo retrograde flexible ureteroscopy (FURS) with antegrade suction, using a percutaneous nephrostomy (PCN) access for suctioning from the kidney during the procedure. This method aims to enhance stone fragment clearance and reduce intrarenal pressure without using a ureteral access sheath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years old)
- Patients diagnosed with renal stones (1.5-2 cm) confirmed by non-contrast computed tomography (NCCT)
- Patients undergoing flexible ureteroscopy (FURS) as the primary treatment approach
- Patients with no active urinary tract infection (UTI) at baseline
- Patients who provide written informed consent
Key exclusion criteria (6 listed)
- Patients with anatomical anomalies (e.g., horseshoe kidney, PUJ obstruction)
- Patients with a single functioning kidney
- Pregnant women
- Patients with a history of urological malignancy
- Patients with active bleeding disorders or those on anticoagulant therapy that cannot be safely discontinued
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 & Navigable Suction Ureteral Access Sheath (FANS)The Flexible \& Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy using Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W). | Procedure or surgery | Flexible & Navigable Suction Ureteral Access Sheath (FANS) Group |
| Antegrade Suction via Percutaneous NephrostomyThis technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone fragmentation. This technique aims to improve stone clearance while minimizing ureteral trauma associated with access sheaths. | Procedure or surgery | Antegrade Suction with Flexible Ureteroscopy (FURS) Group |
Primary outcome
Stone-Free Rate (SFR)
Time frame: 1 Month Postoperative
The stone-free rate (SFR) will be assessed one month postoperatively using non-contrast computed tomography (NCCT) to determine the presence or absence of residual stone fragments ≥4 mm. A higher SFR indicates better effectiveness of the intervention.
5 secondary outcomes
Operative Time
Time frame: During Surgery
Intraoperative Bleeding Requiring Intervention
Time frame: During Surgery
Ureteral Injury
Time frame: During Surgery
Postoperative Hematuria
Time frame: Within 7 Days Postoperative
Postoperative Urosepsis
Time frame: Within 7 Days Postoperative
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 21 Mar 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including baseline characteristics, intraoperative details, postoperative outcomes, and complication data for research purposes. No personally identifiable information will be disclosed.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible & Navigable Suction Ureteral Access Sheath (FANS) and Antegrade Suction via Percutaneous Nephrostomy in people with Nephrolithiasis and Urolithiasis, run by Benha University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Tamer Diab, MD (01003583264 ext. +2, tamer.diab@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (SFR) (time frame: 1 Month Postoperative). 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 21 Mar 2025.