Kidney CalculiNCT07866209
Comparison of Suction and Conventional Ureteral Access Sheaths in Kidney Stone Surgery
An observational study of Kidney Calculi and Nephrolithiasis, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to compare conventional and suction (aspiration) ureteral access sheaths used during retrograde intrarenal surgery (RIRS) in adults with kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi, Nephrolithiasis
- What is being tested?
- Conventional Ureteral Access Sheath and Suction Ureteral Access Sheath
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Mar 2026to 1 May 2027
- Phase
- Observational
- 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
Study population: Adult patients with kidney stones who are scheduled to undergo retrograde intrarenal surgery (RIRS) with either a conventional or a suction ureteral access sheath at the Department of Urology, University of Health Sciences Antalya Training and Research Hospital, Antalya, Turkey.
Who may be able to join
- Age 18 years or older
- Kidney stones scheduled for retrograde intrarenal surgery (RIRS)
- Provision of written informed consent
Who cannot join
- Active untreated urinary tract infection
- Uncorrected bleeding disorder or anticoagulant therapy that cannot be discontinued
- Pregnancy
- Anatomical abnormalities of the urinary tract (e.g., ureteral stricture, horseshoe kidney)
- Failure to place a ureteral access sheath
- Incomplete follow-up data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Antalya Training and Research Hospital
Antalya, Muratpasa, 07100
Baran Arslan, MD, +90 5532487485, drbrnarsln@gmail.com
About this study
Official title: Comparison of Conventional and Suction Ureteral Access Sheaths Used During Retrograde Intrarenal Surgery
The goal of this observational study is to compare conventional and suction (aspiration) ureteral access sheaths used during retrograde intrarenal surgery (RIRS) in adults with kidney stones.
The main questions it aims to answer are:
Read more
- Does the use of a suction ureteral access sheath increase the stone-free rate compared with a conventional sheath?
- Does the use of a suction sheath reduce operative time and complications such as postoperative fever and infection?
Researchers will compare patients treated with a conventional ureteral access sheath with patients treated with a suction ureteral access sheath during routine RIRS.
Participants will:
- Undergo RIRS for kidney stones as part of their routine clinical care
- Have their surgical data recorded, including operative time and any complications
- Attend routine follow-up visits, including imaging to assess whether stones remain
Read the detailed description
Retrograde intrarenal surgery (RIRS) is a widely used minimally invasive treatment for kidney stones. Ureteral access sheaths are commonly used during RIRS to facilitate repeated access to the kidney and to help maintain low intrarenal pressure. Suction (aspiration) ureteral access sheaths are a newer type of sheath that allows continuous removal of irrigation fluid and stone fragments during surgery, which may improve stone clearance and reduce infectious complications. This study aims to compare surgical outcomes, stone-free rates, and complication rates between conventional and suction ureteral access sheaths in patients undergoing RIRS. Both sheath types are CE-marked medical devices used within their intended purpose.
- Conditions
- Kidney Calculi, Nephrolithiasis
- Being tested
- Conventional Ureteral Access Sheath, Suction Ureteral Access Sheath
- Keywords
- Retrograde Intrarenal Surgery, Ureteral Access Sheath, Suction Ureteral Access Sheath, Flexible Ureteroscopy, Stone-Free Rate
- 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.
Conventional Ureteral Access SheathDevice
A standard CE-marked ureteral access sheath without suction, placed during RIRS to provide repeated access to the kidney and facilitate irrigation outflow.
Suction Ureteral Access SheathDevice
A CE-marked ureteral access sheath connected to a negative-pressure suction system, placed during RIRS to allow continuous aspiration of irrigation fluid and stone fragments.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Ureteral Access Sheath Group | Adult patients with kidney stones undergoing retrograde intrarenal surgery (RIRS) with a conventional (non-suction) ureteral access sheath as part of routine clinical care. Receives: Device: Conventional Ureteral Access Sheath | |
| Suction Ureteral Access Sheath Group | Adult patients with kidney stones undergoing retrograde intrarenal surgery (RIRS) with a suction (aspiration) ureteral access sheath as part of routine clinical care. Receives: Device: Suction Ureteral Access Sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-Free Rate
Proportion of patients who are stone-free, defined as no residual stone fragments or residual fragments smaller than 4 mm. Stone-free status will be assessed by non-contrast computed tomography (NCCT) or, for radiopaque stones, by plain kidney-ureter-bladder (KUB) radiography.
Measured: 1 month after surgery
Secondary outcomes (5)
Postoperative Fever and Infectious Complications
Proportion of patients who develop postoperative fever (body temperature ≥38°C), urinary tract infection, or sepsis.
Measured: Within 7 days after surgery
Operative Time
Total duration of surgery, measured in minutes from insertion of the ureteroscope to placement of the ureteral stent or end of the procedure
Measured: During surgery
Postoperative Complications
Proportion of patients with postoperative complications, graded according to the Clavien-Dindo classification.
Measured: Within 30 days after surgery
Total Laser Energy
Total laser energy delivered during lithotripsy, measured in kilojoules (kJ) as recorded by the laser device.
Measured: During surgery
Length of Hospital Stay
Duration of hospital stay after surgery, measured in days.
Measured: From surgery to discharge, an average of 1-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start18 Mar 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmut E İslamoglu, Prof. Dr, Study director, University of Health Sciences Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866209
- Sponsor's protocol ID
- HKAEK-25-29-18
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to patient confidentiality and because the informed consent form did not include permission for data sharing. De-identified data may be made available by the corresponding author upon reasonable request and with approval of the ethics committee.
Publications
Zhu Z, Cui Y, Zeng F, Li Y, Chen Z, Hequn C. Comparison of suctioning and traditional ureteral access sheath during flexible ureteroscopy in the treatment of renal stones. World J Urol. 2019 May;37(5):921-929. doi: 10.1007/s00345-018-2455-8. Epub 2018 Aug 17.
PubMed 30120500
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional and Suction Ureteral Access Sheaths Used During Retrograde Intrarenal Surgery
- ClinicalTrials.gov ID
- NCT07866209
- Acronym / sponsor ID
- HKAEK-25-29-18
- Conditions
- Kidney Calculi, Nephrolithiasis
- Keywords
- Retrograde Intrarenal Surgery, Ureteral Access Sheath, Suction Ureteral Access Sheath, Flexible Ureteroscopy, Stone-Free Rate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 8 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.
The goal of this observational study is to compare conventional and suction (aspiration) ureteral access sheaths used during retrograde intrarenal surgery (RIRS) in adults with kidney stones.
The main questions it aims to answer are:
- Does the use of a suction ureteral access sheath increase the stone-free rate compared with a conventional sheath?
- Does the use of a suction sheath reduce operative time and complications such as postoperative fever and infection?
Researchers will compare patients treated with a conventional ureteral access sheath with patients treated with a suction ureteral access sheath during routine RIRS.
Participants will:
- Undergo RIRS for kidney stones as part of their routine clinical care
- Have their surgical data recorded, including operative time and any complications
- Attend routine follow-up visits, including imaging to assess whether stones remain
Detailed description
Retrograde intrarenal surgery (RIRS) is a widely used minimally invasive treatment for kidney stones. Ureteral access sheaths are commonly used during RIRS to facilitate repeated access to the kidney and to help maintain low intrarenal pressure. Suction (aspiration) ureteral access sheaths are a newer type of sheath that allows continuous removal of irrigation fluid and stone fragments during surgery, which may improve stone clearance and reduce infectious complications. This study aims to compare surgical outcomes, stone-free rates, and complication rates between conventional and suction ureteral access sheaths in patients undergoing RIRS. Both sheath types are CE-marked medical devices used within their intended purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Ureteral Access Sheath Group | – | Device: Conventional Ureteral Access SheathAdult patients with kidney stones undergoing retrograde intrarenal surgery (RIRS) with a conventional (non-suction) ureteral access sheath as part of routine clinical care. |
| Suction Ureteral Access Sheath Group | – | Device: Suction Ureteral Access SheathAdult patients with kidney stones undergoing retrograde intrarenal surgery (RIRS) with a suction (aspiration) ureteral access sheath as part of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with kidney stones who are scheduled to undergo retrograde intrarenal surgery (RIRS) with either a conventional or a suction ureteral access sheath at the Department of Urology, University of Health Sciences Antalya Training and Research Hospital, Antalya, Turkey.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Kidney stones scheduled for retrograde intrarenal surgery (RIRS)
- Provision of written informed consent
Key exclusion criteria (6 listed)
- Active untreated urinary tract infection
- Uncorrected bleeding disorder or anticoagulant therapy that cannot be discontinued
- Pregnancy
- Anatomical abnormalities of the urinary tract (e.g., ureteral stricture, horseshoe kidney)
- Failure to place a ureteral access sheath
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 |
|---|---|---|
| Conventional Ureteral Access SheathA standard CE-marked ureteral access sheath without suction, placed during RIRS to provide repeated access to the kidney and facilitate irrigation outflow. | Device | Conventional Ureteral Access Sheath Group |
| Suction Ureteral Access SheathA CE-marked ureteral access sheath connected to a negative-pressure suction system, placed during RIRS to allow continuous aspiration of irrigation fluid and stone fragments. | Device | Suction Ureteral Access Sheath Group |
Primary outcome
Stone-Free Rate
Time frame: 1 month after surgery
Proportion of patients who are stone-free, defined as no residual stone fragments or residual fragments smaller than 4 mm. Stone-free status will be assessed by non-contrast computed tomography (NCCT) or, for radiopaque stones, by plain kidney-ureter-bladder (KUB) radiography.
5 secondary outcomes
Postoperative Fever and Infectious Complications
Time frame: Within 7 days after surgery
Operative Time
Time frame: During surgery
Postoperative Complications
Time frame: Within 30 days after surgery
Total Laser Energy
Time frame: During surgery
Length of Hospital Stay
Time frame: From surgery to discharge, an average of 1-3 days
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 8 Oct 2026.
- Background: PubMed 30120500Zhu Z, Cui Y, Zeng F, Li Y, Chen Z, Hequn C. Comparison of suctioning and traditional ureteral access sheath during flexible ureteroscopy in the treatment of renal stones. World J Urol. 2019 May;37(5):921-929. doi: 10.1007/s00345-018-2455-8. Epub 2018 Aug 17.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to patient confidentiality and because the informed consent form did not include permission for data sharing. De-identified data may be made available by the corresponding author upon reasonable request and with approval of the ethics committee.
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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.
Mahmut E İslamoglu, Prof. Dr study director
University of Health Sciences Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Calculi and Nephrolithiasis, run by Antalya Health Sciences 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 3 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: looking for participants now, as of the sponsor's last update on 8 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?
Contact Baran Arslan (+90 5532487485, drbrnarsln@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-Free Rate (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07866209, which also lists 1 linked publication.
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 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.