Kidney StoneNCT07615452
Evaluation of Renal Injury After RIRS Using Shear-Wave Elastography
A study testing Aspiration-assisted ureteral access sheath and Standard ureteral access sheath in people with Kidney Stone, run by Cengiz Canakci, MD.
Trial summary
This study aims to evaluate changes in renal parenchyma following retrograde intrarenal surgery (RIRS) using shear-wave elastography. Renal elastography measurements will be performed in patients undergoing RIRS for kidney stones on the preoperative day, on the first postoperative day, and on the seventh postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Aspiration-assisted ureteral access sheath and Standard ureteral access sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Nov 2026
- Phase
- Interventional
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
- Patients undergoing RIRS for renal stones
- Stone size between < 20 mm
- Negative urine culture
Who cannot join
- Active urinary tract infection
- Congenital renal anomalies
- Solitary kidney
- Chronic kidney disease
- Previous PCNL or open surgery
- Ureteral stricture disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Renal Parenchymal Damage Following Retrograde Intrarenal Surgery Using Shear-Wave Elastography
This study aims to evaluate changes in renal parenchyma following retrograde intrarenal surgery (RIRS) using shear-wave elastography. Renal elastography measurements will be performed in patients undergoing RIRS for kidney stones on the preoperative day, on the first postoperative day, and on the seventh postoperative day. Postoperative pain scores, perioperative outcomes, stone-free status and complications will also be assessed.
- Conditions
- Kidney Stone
- Being tested
- Aspiration-assisted ureteral access sheath, Standard ureteral access sheath
- Keywords
- Retrograde intrarenal surgery, Shear-wave elastography, Kidney injury, kidney stone
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration-assisted ureteral access sheathDevice
Patients undergoing retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath
Standard ureteral access sheathDevice
Standard ureteral access sheath used during retrograde intrarenal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Aspiration-assisted ureteral access sheath | Experimental | Patients will undergo retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath. Receives: Device: Aspiration-assisted ureteral access sheath |
| Standard ureteral access sheath | Active comparator | Patients will undergo retrograde intrarenal surgery using a standard ureteral access sheath. Receives: Device: Standard ureteral access sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Cortical Shear-Wave Elastography Values (kPa)
Renal cortical stiffness will be quantitatively evaluated using ultrasound-based shear-wave elastography. Measurements will be obtained from multiple regions of the renal cortex, and the mean value of these measurements will be recorded in kilopascals (kPa). All examinations will be performed using the same ultrasound device and standardized protocol by a single experienced radiologist blinded to the study groups.
Measured: Elastography assessments will be performed preoperatively, on postoperative day 1, and on postoperative day 7 to evaluate perioperative renal parenchymal changes.
Secondary outcomes (7)
Postoperative Complications
Perioperative and postoperative complications assessed according to the Clavien-Dindo classification system.
Measured: From surgery to postoperative day 30
Serum Creatinine Level
Serum creatinine levels measured to evaluate renal function changes following retrograde intrarenal surgery.
Measured: Preoperative baseline, postoperative day 1, and postoperative day 7
Postoperative Fever and Sepsis
Occurrence of postoperative fever (>38°C) and/or sepsis following surgery.
Measured: From surgery to postoperative day 30
Stone-Free Rate
Stone-free status assessed by postoperative imaging.
Measured: Postoperative month 1
Renal Resistive Index
Renal resistive index values measured using Doppler ultrasonography to evaluate renal vascular resistance following retrograde intrarenal surgery.
Measured: Preoperative baseline, postoperative day 1 and postoperative day 7
Mayo Adhesive Probability Score
Perinephric fat adhesion severity assessed using the Mayo Adhesive Probability (MAP) Score based on preoperative computed tomography findings. The MAP Score ranges from 0 to 5, with higher scores indicating a greater likelihood of adherent perinephric fat and increased surgical complexity.
Measured: Preoperative period
Postoperative Pain Scores
. Postoperative pain intensity was assessed using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the most severe pain imaginable. Higher scores indicate greater pain intensity.
Measured: preoperative, postoperative 6th hour, and postoperative 24th hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cengiz Canakci, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cengiz Canakci, MD, Lütfi Kırdar City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615452
- Sponsor's protocol ID
- canakci 003
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No