NephrolithiasisNCT06862141
Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Management of Renal Stones Using Flexible Ureteroscopy
A study testing bendable suction ureteral access sheath and conventional suction ureteral access sheath in people with Nephrolithiasis and Flexible Ureteroscopy, run by Menoufia University at 1 site in Egypt.
Trial summary
Urinary calculus is a globally recognized urological condition, with prevalence rates ranging from 1% to 13% across different geographical regions (1) Therapeutic approaches for renal calculi encompass extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical techniques, such as… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nephrolithiasis, Flexible Ureteroscopy
- What is being tested?
- bendable suction ureteral access sheath and conventional suction ureteral access sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Radiologically confirmed renal stones (e.g., CT, ultrasound, or X-ray).
- Stone size within a specific range (e.g., 5-20 mm).
- Indication for Treatment: patients indicated for flexible ureteroscopy due to renal stones.
- Anatomical Suitability: normal or mildly altered renal anatomy that allows safe use of the access sheath.
- Willingness to participate and provide written informed consent.
Who cannot join
- - Medical Conditions: Active urinary tract infection (UTI) or sepsis. Coagulopathy or inability to discontinue anticoagulation therapy. Significant comorbidities (e.g., severe cardiopulmonary disease). Pregnancy: Pregnant or breastfeeding individuals.
- Anatomical or Surgical Factors:
- Severe ureteral stricture or obstruction preventing sheath placement. Congenital abnormalities affecting the urinary tract. - Stone Factors: Stones larger than the sheath's operational limit (e.g., >20 mm). Multiple stones in different calyces that cannot be accessed in one session.
- Previous Treatment: Recent (<6 weeks) or repeated interventions for the same stones (e.g., prior lithotripsy or ureteroscopy).
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
Faculty of Medicine, Menoufia University
Shebin Elkom, Menoufia, 35111
Mohamed Ibrahim Abozaid, +201068588750, Mabuzaid84@yahoo.com
About this study
Official title: Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Treatment of Renal Stones Using Flexible Ureteroscopy: a Randomized Clinical Trial
Urinary calculus is a globally recognized urological condition, with prevalence rates ranging from 1% to 13% across different geographical regions (1) Therapeutic approaches for renal calculi encompass extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers. According to the guidelines of American Urologic Association (AUA) and European Association of Urology (EAU), patients with a burden of less than 20 mm in kidney calculi can choose RIRS as the frst-line surgical treatment with good stone-free rate (SFR). (2, 3) The application of RIRS for urinary stones has increased signifcantly, and the indications have expanded due to developments in minimally invasive technology and equipment. (4) With the development of stone retrieval devices and miniaturized fexible ureteroscopes, RIRS is more widely used for treating renal calculi, even for high burden stones. (5, 6) The application of ureteral access sheath (UAS) in RIRS can improve surgical vision, reduce intrarenal pressure (IRP), and decrease postoperative infectious complications. (7-9) Several reports have demonstrated the superiority of suctioning UAS, including shorter operation time, higher SFR and lower incidence of infectious complications compared with traditional ureteral access sheath, but none of these suctioning UAS can reach the renal calyces. (10-12)
A novel tip-flexible suctioning ureteral access sheath with flexible terminal was designed, which delivered the tip of the ureteral access sheath to renal calyces. However, data comparing novel tip-flexible suctioning ureteral access and traditional ureteral access sheath is lacking in RIRS.
Therefore, we designed a prospective controlled analysis to compare the efficacy and safety of novel tip-flexible suctioning ureteral access sheath and traditional ureteral access sheath combined with flexible ureteroscope (FURS) in treating renal calculi.
- Conditions
- Nephrolithiasis, Flexible Ureteroscopy
- Being tested
- bendable suction ureteral access sheath, conventional suction ureteral access sheath
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendable suction ureteral access sheathDevice
flexible ureteroscopy will be done using bendable suction ureteral access sheath
conventional suction ureteral access sheathDevice
flexible ureteroscopy will be done using conventional suction ureteral access sheath
| Study group | Role | What they receive |
|---|---|---|
| bendable suction ureteral access sheath | Experimental | this group will undergo flexible ureteroscopy using bendable suction ureteral access sheath Receives: Device: bendable suction ureteral access sheath |
| conventional ureteral access sheath | Experimental | this group will undergo flexible ureteroscopy using conventional ureteral access sheath Receives: Device: conventional suction ureteral access sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate stone free rate
measured by the number of cases has the status of No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.
Measured: one day postoperative
Secondary outcomes (5)
3 month stone free rate
measured by number of cases has the status of No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.
Measured: 3 months postoperatively
duration of hospital stay
measured by number of days from the day of operation till the discharge day
Measured: 2 weeks
secondary intervention
measured by the number of interventions received post randomization
Measured: 3 months
complications
measured by the number of complications experienced by the patients
Measured: 3 months
costs
measured by the total costs of patient during hospitalization and up to 3 months
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Oct 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 NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelazez Anwar Nuser, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862141
- Sponsor's protocol ID
- FANS protocol
- Status last verified
- Feb 2025
- First submitted
- 1 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bendable Suction Ureteral Access Sheath Versus Conventional Ureteral Access Sheath in Treatment of Renal Stones Using Flexible Ureteroscopy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06862141
- Acronym / sponsor ID
- FANS protocol
- Conditions
- Nephrolithiasis, Flexible Ureteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 6 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.
Urinary calculus is a globally recognized urological condition, with prevalence rates ranging from 1% to 13% across different geographical regions (1) Therapeutic approaches for renal calculi encompass extracorporeal shock wave lithotripsy (ESWL) and minimally invasive endoscopic surgical techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS). Treatment plans depend on the characteristics of calculi, patient factors, surgeon experience and the condition of medical centers. According to the guidelines of American Urologic Association (AUA) and European Association of Urology (EAU), patients with a burden of less than 20 mm in kidney calculi can choose RIRS as the frst-line surgical treatment with good stone-free rate (SFR). (2, 3) The application of RIRS for urinary stones has increased signifcantly, and the indications have expanded due to developments in minimally invasive technology and equipment. (4) With the development of stone retrieval devices and miniaturized fexible ureteroscopes, RIRS is more widely used for treating renal calculi, even for high burden stones. (5, 6) The application of ureteral access sheath (UAS) in RIRS can improve surgical vision, reduce intrarenal pressure (IRP), and decrease postoperative infectious complications. (7-9) Several reports have demonstrated the superiority of suctioning UAS, including shorter operation time, higher SFR and lower incidence of infectious complications compared with traditional ureteral access sheath, but none of these suctioning UAS can reach the renal calyces. (10-12)
A novel tip-flexible suctioning ureteral access sheath with flexible terminal was designed, which delivered the tip of the ureteral access sheath to renal calyces. However, data comparing novel tip-flexible suctioning ureteral access and traditional ureteral access sheath is lacking in RIRS.
Therefore, we designed a prospective controlled analysis to compare the efficacy and safety of novel tip-flexible suctioning ureteral access sheath and traditional ureteral access sheath combined with flexible ureteroscope (FURS) in treating renal calculi.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bendable suction ureteral access sheath | Experimental | Device: bendable suction ureteral access sheaththis group will undergo flexible ureteroscopy using bendable suction ureteral access sheath |
| conventional ureteral access sheath | Experimental | Device: conventional suction ureteral access sheaththis group will undergo flexible ureteroscopy using conventional ureteral access sheath |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis: Radiologically confirmed renal stones (e.g., CT, ultrasound, or X-ray).
- Stone size within a specific range (e.g., 5-20 mm).
- Indication for Treatment: patients indicated for flexible ureteroscopy due to renal stones.
- Anatomical Suitability: normal or mildly altered renal anatomy that allows safe use of the access sheath.
- Willingness to participate and provide written informed consent.
Key exclusion criteria (4 listed)
- - Medical Conditions: Active urinary tract infection (UTI) or sepsis. Coagulopathy or inability to discontinue anticoagulation therapy. Significant comorbidities (e.g., severe cardiopulmonary disease). Pregnancy: Pregnant or breastfeeding individuals.
- Anatomical or Surgical Factors:
- Severe ureteral stricture or obstruction preventing sheath placement. Congenital abnormalities affecting the urinary tract. - Stone Factors: Stones larger than the sheath's operational limit (e.g., >20 mm). Multiple stones in different calyces that cannot be accessed in one session.
- Previous Treatment: Recent (<6 weeks) or repeated interventions for the same stones (e.g., prior lithotripsy or ureteroscopy).
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 |
|---|---|---|
| bendable suction ureteral access sheathflexible ureteroscopy will be done using bendable suction ureteral access sheath | Device | bendable suction ureteral access sheath |
| conventional suction ureteral access sheathflexible ureteroscopy will be done using conventional suction ureteral access sheath | Device | conventional ureteral access sheath |
Primary outcome
Immediate stone free rate
Time frame: one day postoperative
measured by the number of cases has the status of No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.
5 secondary outcomes
3 month stone free rate
Time frame: 3 months postoperatively
duration of hospital stay
Time frame: 2 weeks
secondary intervention
Time frame: 3 months
complications
Time frame: 3 months
costs
Time frame: 3 months postoperatively
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 11 Mar 2025.
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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 bendable suction ureteral access sheath and conventional suction ureteral access sheath in people with Nephrolithiasis and Flexible Ureteroscopy, run by Menoufia 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 5 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 11 Mar 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 Mohamed Kamal Omar (+201066949454, kimo_81eg@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate stone free rate (time frame: one day 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 11 Mar 2025.