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Not yet recruitingNCT07615452Updated Jun 3, 2026

Evaluation of Renal Injury After RIRS Using Shear-Wave Elastography

An interventional study of Aspiration-assisted ureteral access sheath and Standard ureteral access sheath in Kidney Stone, sponsored by Cengiz Canakci, MD. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Cengiz Canakci, MD · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 day. Postoperative pain scores, perioperative outcomes, stone-free status and complications will also be assessed.

02

Conditions studied

  • Kidney Stone

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Keywords

  • Retrograde intrarenal surgery
  • Shear-wave elastography
  • Kidney injury
  • kidney stone
03

In context

Kidney Calculi

598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.

This study's planned enrollment of 60 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Cengiz Canakci, MD is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥18 years
  • Patients undergoing RIRS for renal stones
  • Stone size between \< 20 mm
  • Negative urine culture

Exclusion criteria

Exclusion Criteria:

  • Active urinary tract infection
  • Congenital renal anomalies
  • Solitary kidney
  • Chronic kidney disease
  • Previous PCNL or open surgery
  • Ureteral stricture disease
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Aspiration-assisted ureteral access sheath

    Patients will undergo retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath.

    Device: Aspiration-assisted ureteral access sheath

  • Active comparator
    Standard ureteral access sheath

    Patients will undergo retrograde intrarenal surgery using a standard ureteral access sheath.

    Device: Standard ureteral access sheath

Interventions

  • DeviceAspiration-assisted ureteral access sheath

    Patients undergoing retrograde intrarenal surgery using an aspiration-assisted ureteral access sheath

  • DeviceStandard ureteral access sheath

    Standard ureteral access sheath used during retrograde intrarenal surgery.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Elastography assessments will be performed preoperatively, on postoperative day 1, and on postoperative day 7 to evaluate perioperative renal parenchymal changes.

Secondary outcomes

  1. Postoperative Complications

    Perioperative and postoperative complications assessed according to the Clavien-Dindo classification system.

    Time frame: From surgery to postoperative day 30

  2. Serum Creatinine Level

    Serum creatinine levels measured to evaluate renal function changes following retrograde intrarenal surgery.

    Time frame: Preoperative baseline, postoperative day 1, and postoperative day 7

  3. Postoperative Fever and Sepsis

    Occurrence of postoperative fever (\>38°C) and/or sepsis following surgery.

    Time frame: From surgery to postoperative day 30

  4. Stone-Free Rate

    Stone-free status assessed by postoperative imaging.

    Time frame: Postoperative month 1

  5. Renal Resistive Index

    Renal resistive index values measured using Doppler ultrasonography to evaluate renal vascular resistance following retrograde intrarenal surgery.

    Time frame: Preoperative baseline, postoperative day 1 and postoperative day 7

  6. 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.

    Time frame: Preoperative period

  7. 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.

    Time frame: preoperative, postoperative 6th hour, and postoperative 24th hour.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07615452
Lead sponsor
Cengiz Canakci, MD
Responsible party
Cengiz Canakci, MD (Assos. Prof., Lütfi Kırdar City Hospital) — Sponsor-investigator
First posted
May 29, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Jun 3, 2026

Study contacts

Cengiz Çanakcı
Contact
cengizcanakci@hotmail.com
+905454738043

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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