Kidney StoneELITENCT06576661
Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes
A study testing INTRARENAL PRESSURE MONITORING VISIBLE in people with Kidney Stone and Nephrolithiasis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone, Nephrolithiasis
- What is being tested?
- INTRARENAL PRESSURE MONITORING VISIBLE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to 1 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Jane Ledesma, BS, 913-588-8721, jledesma2@kumc.edu
About this study
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.
Read the 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.
- Conditions
- Kidney Stone, Nephrolithiasis
- Being tested
- INTRARENAL PRESSURE MONITORING VISIBLE
- Keywords
- Intrarenal Pressure, LithoVue Elite
- 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.
INTRARENAL PRESSURE MONITORING VISIBLEDevice
In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.
| Study group | Role | What they receive |
|---|---|---|
| URS WITH INTRARENAL PRESSURE MONITORING VISIBLE | Active comparator | In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care. Receives: Device: INTRARENAL PRESSURE MONITORING VISIBLE |
| URS WITHOUT INTRARENAL PRESSURE MONITORING VISIBLE | No intervention | In Arm 2, participants will undergo URS LithoVue Elite™ without the real-time IRP monitoring information visible to the surgeon. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score.
Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication \& teamwork, and leadership.
Measured: Procedure
Secondary outcomes (5)
Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores
Treating investigators will be evaluated using the modified NOTSS tool during the procedure. The NOTSS is used to measure non-technical skills in the operation room in the following categories; situation awareness, decision making, communication \& teamwork, and leadership.
Measured: Procedure
Post-operative infection
Patient signs and symptoms concerning for a urinary tract infection, along with a positive urine culture
Measured: 30-days post-operative
Perioperative patient outcomes as measured by Clavien-Dindo classification system
Intraoperative complications will be categorized based on the Clavien-Dindo classification system
Measured: Up to 30 days
Post-operative pain as measured by Visual analog scale (VAS)
The VAS is a valid and reliable method for quantifying pain intensity on a scale of 0 to 10, where 0 represents no pain and 10 represents the most severe pain possible.
Measured: Immediately post-operative and up to 7 days
Post-operative pain as measured by opioid use
Opioid usage will be tracked
Measured: Immediately post-operative and up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start28 Jan 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bristol Whiles, MD, University of Kansas Medical Center
- Investigators
- Bristol B Whiles, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576661
- Sponsor's protocol ID
- STUDY00160851
- Acronym
- ELITE
- Status last verified
- May 2026
- First submitted
- 26 Aug 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 16857439Baker 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.
PubMed 15159366Yule 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.
PubMed 16455321Yule 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.
PubMed 17054619Brunckhorst 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.
PubMed 28723441Tokas 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.
PubMed 29915944