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

NCT ID: NCT06576661

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-28
• Study Completion Date: 2025-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

URS WITH INTRARENAL PRESSURE MONITORING VISIBLE

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.

Group Type: ACTIVE_COMPARATOR

INTRARENAL PRESSURE MONITORING VISIBLE

Intervention Type: DEVICE

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

URS WITHOUT INTRARENAL PRESSURE MONITORING VISIBLE

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

INTRARENAL PRESSURE MONITORING VISIBLE

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

Intervention Type: DEVICE

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

1. Undergoing bilateral stone treatment during the same procedure

2. Patients with known genitourinary anatomical abnormalities

3. Uncorrected coagulopathy

4. Patients with urinary diversions

5. Chronic external urinary catheters

6. Women who are pregnant

7. Immunosuppressed patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bristol Whiles, MD

Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bristol B Whiles, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jane Ledesma

Role: CONTACT

jledesma2@kumc.edu

19135888721

Facility Contacts

Jane Ledesma, BS

Role: primary

jledesma2@kumc.edu

913-588-8721

References

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.

Reference Type: BACKGROUND

PMID: 16857439 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15159366 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16455321 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17054619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28723441 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29915944 (View on PubMed)

Other Identifiers

STUDY00160851

Identifier Type: -

Identifier Source: org_study_id