NephrolithiasisNCT07898020
Ureteral Access Strategies in Retrograde Intrarenal Surgery
A study testing Flexible and navigable suction ureteral access sheath, Conventional ureteral access sheath and Sheathless flexible ureteroscopy in people with Nephrolithiasis and Kidney Calculi, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Retrograde intrarenal surgery (RIRS) is a standard minimally invasive treatment for kidney stones up to 20 mm. During the procedure, irrigation fluid raises the pressure inside the kidney and laser energy raises the fluid temperature. High intrarenal pressure has been linked to postoperative pain, fever and infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Kidney Calculi, Retrograde Intrarenal Surgery
- What is being tested?
- Flexible and navigable suction ureteral access sheath, Conventional ureteral access sheath and Sheathless flexible ureteroscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Jul 2027
- 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
- Age 18 years or older
- Single or multiple unilateral kidney stones with a largest stone diameter of 20 mm or less, confirmed by non-contrast computed tomography (CT)
- Scheduled for elective retrograde intrarenal surgery (RIRS)
- Provided written informed consent
Who cannot join
- Pregnancy or breastfeeding
- Untreated urinary tract infection
- Concomitant ureteral stone
- Congenital renal anomaly, ureteropelvic junction obstruction or ureteral stricture
- Ipsilateral kidney surgery within the previous 3 months
- Preoperative double-J stent or nephrostomy tube
Show all 10Show fewer
- Regular analgesic use due to other conditions, or chronic pain syndrome
- Neuropsychological disorders that impair postoperative communication (e.g., dementia, intellectual disability)
- Planned bilateral procedure in the same session
- Uncorrectable coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Flexible and Navigable Suction Ureteral Access Sheath (FANS), Conventional Ureteral Access Sheath and Sheathless Approach on Intraoperative Parameters and Postoperative Clinical Outcomes in Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Trial
Retrograde intrarenal surgery (RIRS) is a standard minimally invasive treatment for kidney stones up to 20 mm. During the procedure, irrigation fluid raises the pressure inside the kidney and laser energy raises the fluid temperature. High intrarenal pressure has been linked to postoperative pain, fever and infection. Ureteral access sheaths are used to improve fluid outflow, and newer flexible and navigable suction access sheaths (FANS) add active aspiration to keep pressure low and remove stone fragments.
This randomized controlled trial compares three ureteral access strategies in adults undergoing RIRS: a flexible and navigable suction access sheath, a conventional ureteral access sheath, and no access sheath. The main question is whether the access strategy affects pain 6 hours after surgery. The study also compares intrarenal pressure and temperature during surgery, the amount of irrigation fluid used and retained, stone-free status on computed tomography (CT), and complications.
Read the detailed description
Study design: This is a single-center, prospective, randomized, controlled, three-arm, parallel-group trial conducted at the Department of Urology, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.
Participants and randomization: Adults with unilateral kidney stones up to 20 mm who are scheduled for elective RIRS will be randomized in a 1:1:1 ratio to one of three groups: (1) flexible and navigable suction ureteral access sheath, (2) conventional ureteral access sheath, or (3) sheathless flexible ureteroscopy. Allocation will follow a computer-generated block randomization list and will be concealed in sequentially numbered, opaque, sealed envelopes opened after induction of anesthesia. Patients, the investigator recording pain scores, and the radiologist evaluating CT scans will be blinded to group allocation; the surgeon cannot be blinded.
Surgical procedure: All procedures will follow a standardized protocol: sterile preoperative urine culture, antibiotic prophylaxis, general anesthesia, semirigid diagnostic ureteroscopy with passive ureteral dilatation, a flexible ureteroscope with integrated intrarenal pressure sensing, Holmium:YAG laser lithotripsy with standardized settings, standardized saline irrigation, and placement of a double-J stent at the end of the procedure.
Intraoperative measurements: Intrarenal pressure will be recorded continuously from entry into the collecting system until the end of lithotripsy. Mean, maximum and time above 30 mmHg will be calculated. Intrarenal fluid temperature will be recorded with a temperature probe, and mean, maximum and time above 43 degrees Celsius will be calculated. Irrigation volume will be measured by weighing saline bags. Aspirated volume (suction sheath group) and collected outflow volume (all groups, using a fluid-collection drape) will be measured, and retained fluid will be calculated as irrigation volume minus aspirated and collected volumes. Stone volume will be calculated on preoperative non-contrast CT.
Postoperative assessment: All patients will receive a standardized postoperative analgesic regimen, and any rescue analgesia will be recorded. Pain will be assessed with a 0-10 visual analog scale (VAS) at 1, 2, 6 and 24 hours after surgery. Stone-free status will be assessed by low-dose non-contrast CT on postoperative day 1; patients with residual fragments will undergo repeat CT at 3 months. Complications will be graded with the Clavien-Dindo classification, and ureteral wall injury will be graded with the PULS classification at the end of the procedure.
Sample size and analysis: A sample of 43 patients per group (129 in total) was calculated to detect a 1.5-point difference in 6-hour VAS score between groups (standard deviation 2.0, alpha 0.0167 with Bonferroni correction for three pairwise comparisons, 80% power, 10% dropout). Groups will be compared using ANOVA or Kruskal-Wallis tests for continuous variables and chi-square or Fisher exact tests for categorical variables. Repeated VAS measurements will be analyzed with a linear mixed model, and the relationship between intrarenal pressure and postoperative pain will be assessed with correlation and multiple linear regression analyses. Analyses will be performed on an intention-to-treat basis.
- Conditions
- Nephrolithiasis, Kidney Calculi, Retrograde Intrarenal Surgery, Flexible Ureteroscopy, Ureteral Access Sheath, Suction Sheath
- Being tested
- Flexible and navigable suction ureteral access sheath, Conventional ureteral access sheath, Sheathless flexible ureteroscopy, Retrograde intrarenal surgery with laser lithotripsy
- Medical subject headings
- Nephrolithiasis, Kidney Calculi, Pain, Postoperative
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 sheathDevice
A [10/12] Fr flexible and navigable suction ureteral access sheath ([brand/model]) with a flexible distal tip that follows the ureteroscope into the renal calyces. The side port is connected to a suction unit set at [x] mmHg, providing continuous aspiration of irrigation fluid and stone fragments during lithotripsy.
Conventional ureteral access sheathDevice
A [10/12] Fr standard (non-suction) ureteral access sheath ([brand/model]) placed with its tip at the level of the ureteropelvic junction. Irrigation fluid drains passively through the sheath around the ureteroscope.
Sheathless flexible ureteroscopyProcedure or surgery
Flexible ureteroscopy performed without a ureteral access sheath. The flexible ureteroscope is advanced over a guidewire after diagnostic semirigid ureteroscopy and passive ureteral dilatation.
Retrograde intrarenal surgery with laser lithotripsyProcedure or surgery
Standardized retrograde intrarenal surgery under general anesthesia using a flexible ureteroscope with integrated intrarenal pressure sensing and Holmium:YAG laser lithotripsy with standardized settings. Intrarenal pressure and fluid temperature are recorded continuously, irrigation and outflow volumes are measured, and a double-J stent is placed at the end of the procedure in all patients.
| Study group | Role | What they receive |
|---|---|---|
| Flexible and Navigable Suction Ureteral Access Sheath (FANS) | Experimental | A commercially available flexible and navigable suction ureteral access sheath with a flexible distal tip, placed over a guidewire under fluoroscopic guidance. Continuous aspiration of irrigation fluid and stone fragments is applied through the sheath at a standardized suction pressure during laser lithotripsy. Receives: Device: Flexible and navigable suction ureteral access sheath; Procedure: Retrograde intrarenal surgery with laser lithotripsy |
| Conventional Ureteral Access Sheath | Active comparator | A commercially available standard (non-suction) ureteral access sheath, placed over a guidewire under fluoroscopic guidance with its tip at the level of the ureteropelvic junction. Irrigation fluid drains passively through the sheath around the ureteroscope. Receives: Device: Conventional ureteral access sheath; Procedure: Retrograde intrarenal surgery with laser lithotripsy |
| Sheathless Flexible Ureteroscopy | Active comparator | Patients undergo retrograde intrarenal surgery without a ureteral access sheath. After diagnostic semirigid ureteroscopy and passive ureteral dilatation, the flexible ureteroscope is advanced directly over a guidewire into the collecting system. Irrigation fluid drains passively alongside the ureteroscope. All other surgical steps, irrigation settings, laser settings and postoperative care are identical to the other arms. Receives: Procedure: Sheathless flexible ureteroscopy; Procedure: Retrograde intrarenal surgery with laser lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Pain intensity measured with a 0-10 visual analog scale (VAS); 0 = no pain, 10 = worst imaginable pain.
Measured: 6 hours after surgery
Secondary outcomes (19)
Postoperative pain scores
Pain intensity measured with a 0-10 visual analog scale (VAS); 0 = no pain, 10 = worst imaginable pain.
Measured: 1, 2 and 24 hours after surgery
Number of rescue analgesic doses
Number of rescue analgesic doses administered in addition to the standardized postoperative analgesic regimen.
Measured: First 24 hours after surgery
Mean intrarenal pressure
Mean intrarenal pressure (mmHg) recorded continuously by the pressure-sensing flexible ureteroscope.
Measured: Intraoperative
Maximum intrarenal pressure
Maximum intrarenal pressure (mmHg) recorded during the procedure.
Measured: Intraoperative
Time with intrarenal pressure above 30 mmHg
Total time (seconds) during which intrarenal pressure exceeds 30 mmHg.
Measured: Intraoperative
Mean intrarenal fluid temperature
Mean intrarenal fluid temperature (degrees Celsius) recorded continuously with a temperature probe.
Measured: Intraoperative
Maximum intrarenal fluid temperature
Maximum intrarenal fluid temperature (degrees Celsius) recorded during the procedure.
Measured: Intraoperative
Time with intrarenal fluid temperature above 43 degrees Celsius
Total time (seconds) during which intrarenal fluid temperature exceeds 43 degrees Celsius.
Measured: Intraoperative
Irrigation fluid volume
Total volume of irrigation fluid used (mL), measured by weighing saline bags.
Measured: Intraoperative
Aspirated fluid volume
Volume of fluid aspirated through the suction sheath (mL); applicable to the FANS group only.
Measured: Intraoperative
Collected outflow volume
Volume of irrigation fluid collected in the fluid-collection drape (mL).
Measured: Intraoperative
Retained irrigation fluid volume
Irrigation volume minus aspirated and collected volumes (mL).
Measured: Intraoperative
Stone-free rate
Percentage of participants without residual stone fragments on non-contrast computed tomography.
Measured: Up to 3 months after surgery
Postoperative fever
Number of participants with body temperature of 38 degrees Celsius or higher.
Measured: Up to 30 days after surgery
Infectious complications
Number of participants who develop systemic inflammatory response syndrome (SIRS) or urosepsis.
Measured: Up to 30 days after surgery
Postoperative complications
Number of participants with any postoperative complication graded according to the Clavien-Dindo classification.
Measured: Up to 30 days after surgery
Ureteral wall injury
Grade of ureteral wall injury according to the Post-Ureteroscopic Lesion Scale (PULS), assessed endoscopically.
Measured: At the end of the procedure
Operative time
Time from insertion of the semirigid ureteroscope to placement of the double-J stent (minutes).
Measured: Perioperative/Periprocedural
Length of hospital stay
Time from surgery to hospital discharge (days).
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (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 Ondokuz Mayıs 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
- Three-arm, parallel-group randomized controlled trial with 1:1:1 allocation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Gulsen, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898020
- Sponsor's protocol ID
- OMU-KAEK-2026-623
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flexible and Navigable Suction Ureteral Access Sheath (FANS), Conventional Ureteral Access Sheath and Sheathless Approach on Intraoperative Parameters and Postoperative Clinical Outcomes in Retrograde Intrarenal Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07898020
- Acronym / sponsor ID
- OMU-KAEK-2026-623
- Conditions
- Nephrolithiasis, Kidney Calculi, Retrograde Intrarenal Surgery, Flexible Ureteroscopy, Ureteral Access Sheath, Suction Sheath
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 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.
Retrograde intrarenal surgery (RIRS) is a standard minimally invasive treatment for kidney stones up to 20 mm. During the procedure, irrigation fluid raises the pressure inside the kidney and laser energy raises the fluid temperature. High intrarenal pressure has been linked to postoperative pain, fever and infection. Ureteral access sheaths are used to improve fluid outflow, and newer flexible and navigable suction access sheaths (FANS) add active aspiration to keep pressure low and remove stone fragments.
This randomized controlled trial compares three ureteral access strategies in adults undergoing RIRS: a flexible and navigable suction access sheath, a conventional ureteral access sheath, and no access sheath. The main question is whether the access strategy affects pain 6 hours after surgery. The study also compares intrarenal pressure and temperature during surgery, the amount of irrigation fluid used and retained, stone-free status on computed tomography (CT), and complications.
Detailed description
Study design: This is a single-center, prospective, randomized, controlled, three-arm, parallel-group trial conducted at the Department of Urology, Ondokuz Mayis University Faculty of Medicine, Samsun, Turkey.
Participants and randomization: Adults with unilateral kidney stones up to 20 mm who are scheduled for elective RIRS will be randomized in a 1:1:1 ratio to one of three groups: (1) flexible and navigable suction ureteral access sheath, (2) conventional ureteral access sheath, or (3) sheathless flexible ureteroscopy. Allocation will follow a computer-generated block randomization list and will be concealed in sequentially numbered, opaque, sealed envelopes opened after induction of anesthesia. Patients, the investigator recording pain scores, and the radiologist evaluating CT scans will be blinded to group allocation; the surgeon cannot be blinded.
Surgical procedure: All procedures will follow a standardized protocol: sterile preoperative urine culture, antibiotic prophylaxis, general anesthesia, semirigid diagnostic ureteroscopy with passive ureteral dilatation, a flexible ureteroscope with integrated intrarenal pressure sensing, Holmium:YAG laser lithotripsy with standardized settings, standardized saline irrigation, and placement of a double-J stent at the end of the procedure.
Intraoperative measurements: Intrarenal pressure will be recorded continuously from entry into the collecting system until the end of lithotripsy. Mean, maximum and time above 30 mmHg will be calculated. Intrarenal fluid temperature will be recorded with a temperature probe, and mean, maximum and time above 43 degrees Celsius will be calculated. Irrigation volume will be measured by weighing saline bags. Aspirated volume (suction sheath group) and collected outflow volume (all groups, using a fluid-collection drape) will be measured, and retained fluid will be calculated as irrigation volume minus aspirated and collected volumes. Stone volume will be calculated on preoperative non-contrast CT.
Postoperative assessment: All patients will receive a standardized postoperative analgesic regimen, and any rescue analgesia will be recorded. Pain will be assessed with a 0-10 visual analog scale (VAS) at 1, 2, 6 and 24 hours after surgery. Stone-free status will be assessed by low-dose non-contrast CT on postoperative day 1; patients with residual fragments will undergo repeat CT at 3 months. Complications will be graded with the Clavien-Dindo classification, and ureteral wall injury will be graded with the PULS classification at the end of the procedure.
Sample size and analysis: A sample of 43 patients per group (129 in total) was calculated to detect a 1.5-point difference in 6-hour VAS score between groups (standard deviation 2.0, alpha 0.0167 with Bonferroni correction for three pairwise comparisons, 80% power, 10% dropout). Groups will be compared using ANOVA or Kruskal-Wallis tests for continuous variables and chi-square or Fisher exact tests for categorical variables. Repeated VAS measurements will be analyzed with a linear mixed model, and the relationship between intrarenal pressure and postoperative pain will be assessed with correlation and multiple linear regression analyses. Analyses will be performed on an intention-to-treat basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group randomized controlled trial with 1:1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Flexible and Navigable Suction Ureteral Access Sheath (FANS) | Experimental | Device: Flexible and navigable suction ureteral access sheath, Procedure: Retrograde intrarenal surgery with laser lithotripsyA commercially available flexible and navigable suction ureteral access sheath with a flexible distal tip, placed over a guidewire under fluoroscopic guidance. Continuous aspiration of irrigation fluid and stone fragments is applied through the sheath at a standardized suction pressure during laser lithotripsy. |
| Conventional Ureteral Access Sheath | Active comparator | Device: Conventional ureteral access sheath, Procedure: Retrograde intrarenal surgery with laser lithotripsyA commercially available standard (non-suction) ureteral access sheath, placed over a guidewire under fluoroscopic guidance with its tip at the level of the ureteropelvic junction. Irrigation fluid drains passively through the sheath around the ureteroscope. |
| Sheathless Flexible Ureteroscopy | Active comparator | Procedure: Sheathless flexible ureteroscopy, Procedure: Retrograde intrarenal surgery with laser lithotripsyPatients undergo retrograde intrarenal surgery without a ureteral access sheath. After diagnostic semirigid ureteroscopy and passive ureteral dilatation, the flexible ureteroscope is advanced directly over a guidewire into the collecting system. Irrigation fluid drains passively alongside the ureteroscope. All other surgical steps, irrigation settings, laser settings and postoperative care are identical to the other arms. |
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
- Single or multiple unilateral kidney stones with a largest stone diameter of 20 mm or less, confirmed by non-contrast computed tomography (CT)
- Scheduled for elective retrograde intrarenal surgery (RIRS)
- Provided written informed consent
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding
- Untreated urinary tract infection
- Concomitant ureteral stone
- Congenital renal anomaly, ureteropelvic junction obstruction or ureteral stricture
- Ipsilateral kidney surgery within the previous 3 months
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 sheathA [10/12] Fr flexible and navigable suction ureteral access sheath ([brand/model]) with a flexible distal tip that follows the ureteroscope into the renal calyces. The side port is connected to a suction unit set at [x] mmHg, providing continuous aspiration of irrigation fluid and stone fragments during lithotripsy. | Device | Flexible and Navigable Suction Ureteral Access Sheath (FANS) |
| Conventional ureteral access sheathA [10/12] Fr standard (non-suction) ureteral access sheath ([brand/model]) placed with its tip at the level of the ureteropelvic junction. Irrigation fluid drains passively through the sheath around the ureteroscope. | Device | Conventional Ureteral Access Sheath |
| Sheathless flexible ureteroscopyFlexible ureteroscopy performed without a ureteral access sheath. The flexible ureteroscope is advanced over a guidewire after diagnostic semirigid ureteroscopy and passive ureteral dilatation. | Procedure or surgery | Sheathless Flexible Ureteroscopy |
| Retrograde intrarenal surgery with laser lithotripsyStandardized retrograde intrarenal surgery under general anesthesia using a flexible ureteroscope with integrated intrarenal pressure sensing and Holmium:YAG laser lithotripsy with standardized settings. Intrarenal pressure and fluid temperature are recorded continuously, irrigation and outflow volumes are measured, and a double-J stent is placed at the end of the procedure in all patients. | Procedure or surgery | Conventional Ureteral Access Sheath, Flexible and Navigable Suction Ureteral Access Sheath (FANS), Sheathless Flexible Ureteroscopy |
Primary outcome
Postoperative pain score
Time frame: 6 hours after surgery
Pain intensity measured with a 0-10 visual analog scale (VAS); 0 = no pain, 10 = worst imaginable pain.
19 secondary outcomes
Postoperative pain scores
Time frame: 1, 2 and 24 hours after surgery
Number of rescue analgesic doses
Time frame: First 24 hours after surgery
Mean intrarenal pressure
Time frame: Intraoperative
Maximum intrarenal pressure
Time frame: Intraoperative
Time with intrarenal pressure above 30 mmHg
Time frame: Intraoperative
Mean intrarenal fluid temperature
Time frame: Intraoperative
Maximum intrarenal fluid temperature
Time frame: Intraoperative
Time with intrarenal fluid temperature above 43 degrees Celsius
Time frame: Intraoperative
Irrigation fluid volume
Time frame: Intraoperative
Aspirated fluid volume
Time frame: Intraoperative
Collected outflow volume
Time frame: Intraoperative
Retained irrigation fluid volume
Time frame: Intraoperative
Stone-free rate
Time frame: Up to 3 months after surgery
Postoperative fever
Time frame: Up to 30 days after surgery
Infectious complications
Time frame: Up to 30 days after surgery
Postoperative complications
Time frame: Up to 30 days after surgery
Ureteral wall injury
Time frame: At the end of the procedure
Operative time
Time frame: Perioperative/Periprocedural
Length of hospital stay
Time frame: Up to 7 days after surgery
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 27 Oct 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.
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, Conventional ureteral access sheath and Sheathless flexible ureteroscopy in people with Nephrolithiasis and Kidney Calculi, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 10 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 27 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 Turkey (Türkiye). 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?
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?
Postoperative pain score (time frame: 6 hours after surgery). 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 27 Oct 2026.