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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Diagnostic (in office ureteroscopy) 		Patients receive lidocaine jelly intraurethrally for local anesthesia. Patients then undergo ureteroscopy using the 6.3 Fr single use digital ureteroscope. Per standard of care practice, patients receive pain medication PO on an as needed basis prior to and immediately after the procedure.
  • Drug: Analgesic Agent
    Given PO
    Other names:
    • analgesic
    • Analgesic Drugs
    • Analgesics
    • Anodynes
    • Antinociceptive Agents
    • Pain-relief Medication
  • 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

Recruiting Locations

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Contact:
Michael Uy, MD
734-936-7030
Uymichae@med.umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan Rogel Cancer Center

Study Contact

Michael Uy, MD
734-936-7030
Uymichae@med.umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.