Kidney StonesNCT07377461
Flexible and Navigable Suction Ureteral Access Sheath (FANS) vs Conventional Access Sheaths in RIRS: A Prospective Randomized Study.
A study testing Flexible and Navigable Suction Ureteral Access Sheath (FANS) and Conventional Ureteral Access Sheath in people with Kidney Stones and Nephrolithiasis, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
Kidney stones located in the kidney are commonly treated using a minimally invasive procedure called retrograde intrarenal surgery (RIRS). During this procedure, a ureteral access sheath is often used to facilitate repeated access to the kidney, improve visualization, and allow irrigation fluid to drain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones, Nephrolithiasis
- What is being tested?
- Flexible and Navigable Suction Ureteral Access Sheath (FANS) and Conventional Ureteral Access Sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2025to 30 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Presence of single or multiple renal stones measuring 10 mm or greater
- Eligible for retrograde intrarenal surgery under general anesthesia
- Ability to provide written informed consent
Who cannot join
- Pregnancy
- Active urinary tract infection at the time of surgery
- Known bleeding disorders
- Solitary kidney
- Anatomical abnormalities of the urinary tract that could affect ureteroscopic access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Access Sheaths With Flexible Tips and Suction Versus Conventional Access in Endourology: A Prospective Study
Kidney stones located in the kidney are commonly treated using a minimally invasive procedure called retrograde intrarenal surgery (RIRS). During this procedure, a ureteral access sheath is often used to facilitate repeated access to the kidney, improve visualization, and allow irrigation fluid to drain.
Newer access sheaths have been developed with flexible distal tips and built-in suction capabilities, which may help reduce operative time by improving visibility and removing stone fragments and irrigation fluid more efficiently.
Read more
This prospective randomized study compared a flexible and navigable suction ureteral access sheath with a conventional ureteral access sheath in adult patients undergoing RIRS for kidney stones measuring 10 mm or larger. Participants were randomly assigned to one of the two access sheath types.
The primary objective of the study was to evaluate whether the use of a suction-enabled access sheath reduces operative time. Secondary objectives included assessment of complications, length of hospital stay, stone-free rate, and need for additional interventions.
Read the detailed description
This was a prospective, single-center, randomized controlled trial conducted at a tertiary referral endourology center. Adult patients (≥18 years) with renal stones measuring 10 mm or greater and scheduled to undergo retrograde intrarenal surgery (RIRS) under general anesthesia were eligible for inclusion.
Participants were randomized in a 1:1 ratio to undergo RIRS using either a flexible and navigable suction ureteral access sheath (FANS group) or a conventional ureteral access sheath (control group). Randomization was performed using a computer-generated sequence with allocation concealment via sealed opaque envelopes. Blinding of the operating surgeon was not feasible due to the nature of the devices used.
All procedures were performed by experienced endourologists using standardized surgical techniques. Flexible ureteroscopy was performed with a digital ureteroscope, and stone fragmentation was achieved using a Holmium:YAG laser in dusting mode. In the suction access sheath group, negative pressure suction was applied through the sheath according to manufacturer guidelines. Irrigation parameters were standardized across both study arms.
The primary outcome measure was operative time, defined as the interval from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure. Secondary outcome measures included intraoperative and postoperative complications (classified using the Clavien-Dindo system), ureteral wall injury, length of hospital stay, stone migration, and stone-free rate. Stone-free status was defined as the absence of residual fragments greater than 2 mm on postoperative imaging.
Preoperative assessment included non-contrast computed tomography to evaluate stone size, location, and burden. Postoperative imaging was performed using kidney-ureter-bladder radiography or renal ultrasound approximately two weeks after surgery.
The study was approved by the Institutional Review Board of Barzilai University Medical Center, and all participants provided written informed consent prior to enrollment.
- Conditions
- Kidney Stones, Nephrolithiasis
- Being tested
- Flexible and Navigable Suction Ureteral Access Sheath (FANS), Conventional Ureteral Access Sheath
- Keywords
- Retrograde Intrarenal Surgery, Ureteral Access Sheath, Suction Ureteral Access Sheath, Flexible Tip Ureteral Access Sheath, RIRS, Operative Time, Endourology
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible and Navigable Suction Ureteral Access Sheath (FANS)Device
Use of a flexible distal-tip ureteral access sheath with integrated suction during retrograde intrarenal surgery to facilitate access, irrigation control, and fragment evacuation.
Conventional Ureteral Access SheathDevice
Use of a standard ureteral access sheath without suction during retrograde intrarenal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Flexible and Navigable Suction Ureteral Access Sheath (FANS) | Experimental | Participants underwent retrograde intrarenal surgery using a flexible and navigable ureteral access sheath with integrated suction capability. Receives: Device: Flexible and Navigable Suction Ureteral Access Sheath (FANS) |
| Conventional Ureteral Access Sheath | Active comparator | Participants underwent retrograde intrarenal surgery using a standard, non-suction ureteral access sheath. Receives: Device: Conventional Ureteral Access Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Operative time was defined as the duration from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure.
Measured: During the surgical procedure
Secondary outcomes (4)
Intraoperative and Postoperative Complications
Intraoperative and postoperative complications were recorded and classified according to the Clavien-Dindo classification system.
Measured: Perioperative period (Day of surgery through postoperative Day 30).
Stone-Free Rate
Stone-free status was defined as the absence of residual stone fragments greater than 2 mm on postoperative imaging.
Measured: Two weeks after surgery
Length of Hospital Stay
Length of hospital stay was defined as the number of days from surgery to hospital discharge.
Measured: From end of surgery until hospital discharge (typically 1-3 days).
Ureteral Wall Injury
Ureteral wall injury was assessed intraoperatively and classified according to the Traxer-Thomas classification system.
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- 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
- Participants were randomized in a 1:1 ratio to one of two parallel intervention arms.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377461
- Sponsor's protocol ID
- 0069-24-BRZ
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Access Sheaths With Flexible Tips and Suction Versus Conventional Access in Endourology: A Prospective Study
- ClinicalTrials.gov ID
- NCT07377461
- Acronym / sponsor ID
- 0069-24-BRZ
- Conditions
- Kidney Stones, Nephrolithiasis
- Keywords
- Retrograde Intrarenal Surgery, Ureteral Access Sheath, Suction Ureteral Access Sheath, Flexible Tip Ureteral Access Sheath, RIRS, Operative Time, Endourology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 30 Jan 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.
Kidney stones located in the kidney are commonly treated using a minimally invasive procedure called retrograde intrarenal surgery (RIRS). During this procedure, a ureteral access sheath is often used to facilitate repeated access to the kidney, improve visualization, and allow irrigation fluid to drain.
Newer access sheaths have been developed with flexible distal tips and built-in suction capabilities, which may help reduce operative time by improving visibility and removing stone fragments and irrigation fluid more efficiently.
This prospective randomized study compared a flexible and navigable suction ureteral access sheath with a conventional ureteral access sheath in adult patients undergoing RIRS for kidney stones measuring 10 mm or larger. Participants were randomly assigned to one of the two access sheath types.
The primary objective of the study was to evaluate whether the use of a suction-enabled access sheath reduces operative time. Secondary objectives included assessment of complications, length of hospital stay, stone-free rate, and need for additional interventions.
Detailed description
This was a prospective, single-center, randomized controlled trial conducted at a tertiary referral endourology center. Adult patients (≥18 years) with renal stones measuring 10 mm or greater and scheduled to undergo retrograde intrarenal surgery (RIRS) under general anesthesia were eligible for inclusion.
Participants were randomized in a 1:1 ratio to undergo RIRS using either a flexible and navigable suction ureteral access sheath (FANS group) or a conventional ureteral access sheath (control group). Randomization was performed using a computer-generated sequence with allocation concealment via sealed opaque envelopes. Blinding of the operating surgeon was not feasible due to the nature of the devices used.
All procedures were performed by experienced endourologists using standardized surgical techniques. Flexible ureteroscopy was performed with a digital ureteroscope, and stone fragmentation was achieved using a Holmium:YAG laser in dusting mode. In the suction access sheath group, negative pressure suction was applied through the sheath according to manufacturer guidelines. Irrigation parameters were standardized across both study arms.
The primary outcome measure was operative time, defined as the interval from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure. Secondary outcome measures included intraoperative and postoperative complications (classified using the Clavien-Dindo system), ureteral wall injury, length of hospital stay, stone migration, and stone-free rate. Stone-free status was defined as the absence of residual fragments greater than 2 mm on postoperative imaging.
Preoperative assessment included non-contrast computed tomography to evaluate stone size, location, and burden. Postoperative imaging was performed using kidney-ureter-bladder radiography or renal ultrasound approximately two weeks after surgery.
The study was approved by the Institutional Review Board of Barzilai University Medical Center, and all participants provided written informed consent prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to one of two parallel intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Flexible and Navigable Suction Ureteral Access Sheath (FANS) | Experimental | Device: Flexible and Navigable Suction Ureteral Access Sheath (FANS)Participants underwent retrograde intrarenal surgery using a flexible and navigable ureteral access sheath with integrated suction capability. |
| Conventional Ureteral Access Sheath | Active comparator | Device: Conventional Ureteral Access SheathParticipants underwent retrograde intrarenal surgery using a standard, non-suction 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 (4 listed)
- Age 18 years or older
- Presence of single or multiple renal stones measuring 10 mm or greater
- Eligible for retrograde intrarenal surgery under general anesthesia
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Pregnancy
- Active urinary tract infection at the time of surgery
- Known bleeding disorders
- Solitary kidney
- Anatomical abnormalities of the urinary tract that could affect ureteroscopic 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 and Navigable Suction Ureteral Access Sheath (FANS)Use of a flexible distal-tip ureteral access sheath with integrated suction during retrograde intrarenal surgery to facilitate access, irrigation control, and fragment evacuation. | Device | Flexible and Navigable Suction Ureteral Access Sheath (FANS) |
| Conventional Ureteral Access SheathUse of a standard ureteral access sheath without suction during retrograde intrarenal surgery. | Device | Conventional Ureteral Access Sheath |
Primary outcome
Operative Time
Time frame: During the surgical procedure
Operative time was defined as the duration from insertion of the first endoscopic instrument through the urethra to removal of the final instrument at the end of the procedure.
4 secondary outcomes
Intraoperative and Postoperative Complications
Time frame: Perioperative period (Day of surgery through postoperative Day 30).
Stone-Free Rate
Time frame: Two weeks after surgery
Length of Hospital Stay
Time frame: From end of surgery until hospital discharge (typically 1-3 days).
Ureteral Wall Injury
Time frame: During the surgical procedure
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 25 Jun 2026.
- Individual participant dataSharing planned: No
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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 and Navigable Suction Ureteral Access Sheath (FANS) and Conventional Ureteral Access Sheath in people with Kidney Stones and Nephrolithiasis, run by Barzilai Medical Center at 1 site in Israel.
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 4 inclusion and 5 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 25 Jun 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 Israel. 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?
Operative Time (time frame: During the surgical procedure). 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 25 Jun 2026.