Menu
Recruiting NCT06576661

Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes

No phase Interventional Kidney Stone Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INTRARENAL PRESSURE MONITORING VISIBLE.
Who it may be relevant to
Registry conditions: Kidney Stone, Nephrolithiasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.

Detailed description

Despite advances in surgical techniques and technology, preventable adverse events still occur in the operating room, with half of them attributed to poor non-technical skills of surgical teams. Therefore, it is essential to observe and measure surgeons' intraoperative non-technical skills and provide structured feedback to improve patient safety. The new LithoVue Elite™ disposable ureteroscope has the potential to impact surgeons' behavior during ureteroscopy, as it enables the measurement of real-time intrarenal pressures. The study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.

Interventions

  • Device INTRARENAL PRESSURE MONITORING VISIBLE
    In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.

Primary outcome measures

  • Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score. [Time frame: Procedure]
Secondary outcome measures (5)
  • Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores [Time frame: Procedure]
  • Post-operative infection [Time frame: 30-days post-operative]
  • Perioperative patient outcomes as measured by Clavien-Dindo classification system [Time frame: Up to 30 days]
  • Post-operative pain as measured by Visual analog scale (VAS) [Time frame: Immediately post-operative and up to 7 days]
  • Post-operative pain as measured by opioid use [Time frame: Immediately post-operative and up to 7 days]

Eligibility criteria

Inclusion criteria

  • Males or females over 18 years of age
  • Undergoing flexible ureteroscopy to address urinary stones located in the proximal ureter or kidney
  • Total stone burden over 2 cm

Exclusion criteria

  • Undergoing bilateral stone treatment during the same procedure
  • Patients with known genitourinary anatomical abnormalities
  • Uncorrected coagulopathy
  • Patients with urinary diversions
  • Chronic external urinary catheters
  • Women who are pregnant
  • Immunosuppressed patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Publications

  • Rogers SO Jr, Gawande AA, Kwaan M, Puopolo AL, Yoon C, Brennan TA, Studdert DM. Analysis of surgical errors in closed malpractice claims at 4 liability insurers. Surgery. 2006 Jul;140(1):25-33. doi: 10.1016/j.surg.2006.01.008. PMID 16857439
  • Baker GR, Norton PG, Flintoft V, Blais R, Brown A, Cox J, Etchells E, Ghali WA, Hebert P, Majumdar SR, O'Beirne M, Palacios-Derflingher L, Reid RJ, Sheps S, Tamblyn R. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. CMAJ. 2004 May 25;170(11):1678-86. doi: 10.1503/cmaj.1040498. PMID 15159366
  • Yule S, Flin R, Paterson-Brown S, Maran N. Non-technical skills for surgeons in the operating room: a review of the literature. Surgery. 2006 Feb;139(2):140-9. doi: 10.1016/j.surg.2005.06.017. PMID 16455321
  • Yule S, Flin R, Paterson-Brown S, Maran N, Rowley D. Development of a rating system for surgeons' non-technical skills. Med Educ. 2006 Nov;40(11):1098-104. doi: 10.1111/j.1365-2929.2006.02610.x. PMID 17054619
  • Brunckhorst O, Volpe A, van der Poel H, Mottrie A, Ahmed K. Training, Simulation, the Learning Curve, and How to Reduce Complications in Urology. Eur Urol Focus. 2016 Apr;2(1):10-18. doi: 10.1016/j.euf.2016.02.004. Epub 2016 Feb 24. PMID 28723441
  • Tokas T, Skolarikos A, Herrmann TRW, Nagele U; Training and Research in Urological Surgery and Technology (T.R.U.S.T.)-Group. Pressure matters 2: intrarenal pressure ranges during upper-tract endourological procedures. World J Urol. 2019 Jan;37(1):133-142. doi: 10.1007/s00345-018-2379-3. Epub 2018 Jun 18. PMID 29915944

Identifiers

NCT: NCT06576661 · STUDY00160851

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗