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

NCT06576661 | Recruiting FDA Device

• 1 other identifier: STUDY00160851
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Stone; Nephrolithiasis

Keywords

Intrarenal Pressure; LithoVue Elite

Outcome Measures

Primary Outcomes (1)

• 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.

  Procedure

Secondary Outcomes (5)

• Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores

  Procedure

• Post-operative infection

  30-days post-operative

• Perioperative patient outcomes as measured by Clavien-Dindo classification system

  Up to 30 days

• Post-operative pain as measured by Visual analog scale (VAS)

  Immediately post-operative and up to 7 days

• Post-operative pain as measured by opioid use

  Immediately post-operative and up to 7 days

Study Arms (2)

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.

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.

Interventions

INTRARENAL PRESSURE MONITORING VISIBLE DEVICE

In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™.

URS WITH INTRARENAL PRESSURE MONITORING VISIBLE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol B Whiles, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Ledesma

CONTACT

19135888721; jledesma2@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Model Details: Parallel assignment

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: January 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)