RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Michigan Rogel Cancer Center • ClinicalTrials.gov ID: NCT07630155

Registry updated: 2026-10-15

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Description

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.

Interventions

Analgesic Agent (Drug)
Given PO
Electronic Health Record Review (Other)
Ancillary studies
Lidocaine Topical (Drug)
Given intraurethrally
Medical Device Usage and Evaluation (Device)
Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope
Survey Administration (Other)
Ancillary studies
Ureteroscopy (Procedure)
Undergo ureteroscopy

Eligibility criteria

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

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

Locations

University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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