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Recruiting NCT07630155

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

No phase Interventional Renal Pelvis and Ureter Urothelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Analgesic Agent, Electronic Health Record Review, Lidocaine Topical, Medical Device Usage and Evaluation.
Who it may be relevant to
Registry conditions: Renal Pelvis and Ureter Urothelial Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Primary outcome measures

  • Success rate [Time frame: On day of procedure]
Secondary outcome measures (3)
  • Pain [Time frame: From baseline up to 7-10 days post procedure]
  • Satisfaction [Time frame: At 7-10 days post procedure]
  • Unplanned healthcare use [Time frame: From baseline up to 30 days post procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of Michigan Rogel Cancer Center — Ann Arbor

Identifiers

NCT: NCT07630155 · UMCC 2025.155 · NCI-2026-03864 · HUM00284243

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗