UrolithiasisTIDAL-fURSNCT07304297
Effect of Tidal Volume on fURS Parameters
A study testing Flexible Ureteroscopy in people with Urolithiasis and Tidal Volume, run by Tarik Emre Sener at 1 site in Turkey (Türkiye).
Trial summary
The goal of this prospective clinical trial is to evaluate how intraoperative tidal volume settings affect surgical parameters and outcomes in adult patients undergoing flexible ureteroscopy (fURS) for kidney stones. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis, Tidal Volume, Flexible Ureteroscopy
- What is being tested?
- Flexible Ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 24 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Unilateral, single kidney stones located in the upper or middle calyx or in the renal pelvis
Who cannot join
- Chronic obstructive pulmonary disease (COPD)
- Pregnancy
- History of abdominal, retroperitoneal, or thoracic surgery
- Kidney anomalies
- Stones located in the lower calyx
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Urology Department
Istanbul, Pendik, 34854
About this study
Official title: Impact of Intraoperative Tidal Volume on Surgical Parameters During Flexible Ureteroscopy
The goal of this prospective clinical trial is to evaluate how intraoperative tidal volume settings affect surgical parameters and outcomes in adult patients undergoing flexible ureteroscopy (fURS) for kidney stones. The participant population includes patients over 18 years of age with unilateral, single renal stones located in the upper/middle calyx or renal pelvis.
This study aims to answer are:
Read more
Does intraoperative tidal volume influence operative time and surgical efficiency during fURS?
Does tidal volume affect laser energy use, lasing efficiency, stone-free rates, and complication rates (infection or bleeding)?
The investigators will compare two groups based on tidal volume recorded during anaesthesia:
Group 1: Low tidal volume (< 500 mL)
Group 2: Standard tidal volume (≥ 500 mL)
to determine whether tidal volume differences impact surgical performance and postoperative outcomes.
Participants will:
Undergo fURS performed under general anaesthesia with standard ASA monitoring, including ETCO₂ and TOF monitoring.
Have their respiratory parameters (tidal volume, peak airway pressure, PEEP, respiratory rate, ETCO₂) and surgical data (operative time, laser settings, fluoroscopy use, stone-free status) recorded during and after surgery.
- Conditions
- Urolithiasis, Tidal Volume, Flexible Ureteroscopy
- Being tested
- Flexible Ureteroscopy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible UreteroscopyProcedure or surgery
Between October 2025 and December 2025, Patients who underwent fURS surgery in our clinic, with the surgical indication determined according to the EAU guidelines, were included in the study. Patients over 18 years of age with unilateral, single stones located in the upper or middle calyx or in the renal pelvis were included in the study. Patients with chronic obstructive pulmonary disease, pregnancy, a history of abdominal, retroperitoneal, or thoracic surgery, kidney anomalies, or stones located in the lower calyx were excluded.
| Study group | Role | What they receive |
|---|---|---|
| Low Tidal Volume | Active comparator | Not described Receives: Procedure: Flexible Ureteroscopy |
| Normal Tidal Volume | Placebo comparator | Not described Receives: Procedure: Flexible Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Intraoperative Respiratory Parameters and Surgical Outcomes
Respiratory parameter measured:
Tidal Volume (mL/kg)
Measurement tool: Anaesthesia ventilator/monitoring system
Unit: milliliters per kilogram (mL/kg)
Surgical outcomes assessed:
Stone-free rate (%), assessed by postoperative non-contrast CT scan
Operative time (minutes), recorded from surgical logs
Complications, graded using the Clavien-Dindo classification
The objective is to determine the statistical correlation between tidal volume and each of these surgical outcomes.
Measured: 2 months
Secondary outcomes (1)
Correlation Between Intraoperative Respiratory Parameters and Seconder Outcomes
Operative time (minutes), recorded from surgical logs
Surgical efficiency (stone volume / operative time, mm³/min)
Laser time (seconds), recorded from laser console
Laser energy used (Joules), recorded from laser console
Lasing efficiency (stone volume / lasing time, mm³/sec)
Complications, graded using the Clavien-Dindo classification
Bleeding rate (%), incidence of significant intra- or postoperative bleeding
Infection rate (%), incidence of postoperative urinary tract infection
Length of hospital stay (days), total postoperative hospitalization
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Sep 2025
- Primary completion23 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarik Emre Sener
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304297
- Sponsor's protocol ID
- MAR.UAD.0026
- Acronym
- TIDAL-fURS
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Tidal Volume on Surgical Parameters During Flexible Ureteroscopy
- ClinicalTrials.gov ID
- NCT07304297
- Acronym / sponsor ID
- TIDAL-fURS / MAR.UAD.0026
- Conditions
- Urolithiasis, Tidal Volume, Flexible Ureteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tarik Emre SenerUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 23 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 26 Dec 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.
The goal of this prospective clinical trial is to evaluate how intraoperative tidal volume settings affect surgical parameters and outcomes in adult patients undergoing flexible ureteroscopy (fURS) for kidney stones. The participant population includes patients over 18 years of age with unilateral, single renal stones located in the upper/middle calyx or renal pelvis.
This study aims to answer are:
Does intraoperative tidal volume influence operative time and surgical efficiency during fURS?
Does tidal volume affect laser energy use, lasing efficiency, stone-free rates, and complication rates (infection or bleeding)?
The investigators will compare two groups based on tidal volume recorded during anaesthesia:
Group 1: Low tidal volume (< 500 mL)
Group 2: Standard tidal volume (≥ 500 mL)
to determine whether tidal volume differences impact surgical performance and postoperative outcomes.
Participants will:
Undergo fURS performed under general anaesthesia with standard ASA monitoring, including ETCO₂ and TOF monitoring.
Have their respiratory parameters (tidal volume, peak airway pressure, PEEP, respiratory rate, ETCO₂) and surgical data (operative time, laser settings, fluoroscopy use, stone-free status) recorded during and after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Tidal Volume | Active comparator | Procedure: Flexible Ureteroscopy |
| Normal Tidal Volume | Placebo comparator | Procedure: Flexible Ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Unilateral, single kidney stones located in the upper or middle calyx or in the renal pelvis
Key exclusion criteria (5 listed)
- Chronic obstructive pulmonary disease (COPD)
- Pregnancy
- History of abdominal, retroperitoneal, or thoracic surgery
- Kidney anomalies
- Stones located in the lower calyx
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 UreteroscopyBetween October 2025 and December 2025, Patients who underwent fURS surgery in our clinic, with the surgical indication determined according to the EAU guidelines, were included in the study. Patients over 18 years of age with unilateral, single stones located in the upper or middle calyx or in the renal pelvis were included in the study. Patients with chronic obstructive pulmonary disease, pregnancy, a history of abdominal, retroperitoneal, or thoracic surgery, kidney anomalies, or stones located in the lower calyx were excluded. | Procedure or surgery | Low Tidal Volume, Normal Tidal Volume |
Primary outcome
Correlation Between Intraoperative Respiratory Parameters and Surgical Outcomes
Time frame: 2 months
Respiratory parameter measured: Tidal Volume (mL/kg) Measurement tool: Anaesthesia ventilator/monitoring system Unit: milliliters per kilogram (mL/kg) Surgical outcomes assessed: Stone-free rate (%), assessed by postoperative non-contrast CT scan Operative time (minutes), recorded from surgical logs Complications, graded using the Clavien-Dindo classification The objective is to determine the statistical correlation between tidal volume and each of these surgical outcomes.
1 secondary outcome
Correlation Between Intraoperative Respiratory Parameters and Seconder Outcomes
Time frame: 2 months
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 26 Dec 2025.
- Individual participant dataSharing planned: Yes
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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 Ureteroscopy in people with Urolithiasis and Tidal Volume, run by Tarik Emre Sener 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 2 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 26 Dec 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 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. Some participants in this study may receive a placebo. 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?
Correlation Between Intraoperative Respiratory Parameters and Surgical Outcomes (time frame: 2 months). 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 26 Dec 2025.