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Brief Title: Office-Based Ureteroscopy Utilizing a Single Use Digital, Flexible Ureteroscope for Upper Tract Urothelial Carcinoma

A Prospective Clinical Assessment of Office-Based Ureteroscopy for Upper Tract Urothelial Carcinoma Utilizing a 6.3 French Single Use Digital Flexible Ureteroscope

INTRODUCTION

  • Org Study ID: UMCC 2025.155
  • Secondary ID: N/A
  • NCT ID: NCT07630155
  • Sponsor: University of Michigan Rogel Cancer Center

BRIEF SUMMARY

This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma. Ureteroscopy is traditionally performed in an operating room under general anesthesia. In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind. Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis. Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.

  • Overall Status
    Recruiting
  • Start Date
    August, 2026
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Success rate

Primary Outcome 1 - Timeframe: On day of procedure

CONDITION

  • Renal Pelvis and Ureter Urothelial Carcinoma

ELIGIBILITY

Inclusion Criteria:
* Provision of signed and dated informed consent form

- * Stated willingness to comply with all study procedures and availability for the duration of the study

- * Male or female, aged ≥ 18 year. Both sexes are included to reflect the patient population with upper tract urothelial carcinoma (UTUC) already being followed at the University of Michigan and allow exploration of potential differences in tolerability of awake ureteroscopy based on sex

- * History of endoscopically managed UTUC at any time, or a suspected diagnosis of UTUC based on pre-procedure imaging, and is already planned for office-based ureteroscopic assessment

- * Ability and willingness to complete and adhere to survey questions and responses throughout study duration
Exclusion Criteria:
* Known ureteral strictures

- * Active urinary tract infection

- * Need for general anesthesia due to patient or procedural factors

- * History of inability to tolerate ureteroscopy under local anesthetic

- * Anticipated need for laser ablation during the surveillance procedure

- * Pregnancy

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Khurshid Ghani, MD

Role: Principal Investigator

Affiliation: University of Michigan Rogel Cancer Center

Overall Contact

Name: Michael Uy, MD

Phone: 734-936-7030

Email: [email protected]

LOCATION

Facility Status Contact
Facility: University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Contact
Michael Uy, MD
734-936-7030
[email protected]

Principal Investigator
Khurshid Ghani, MD