Office-based ureteroscopy using a single-use digital flexible ureteroscope for upper tract urothelial carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores office-based ureteroscopy with a single-use digital, flexible ureteroscope to evaluate upper tract urothelial carcinoma. Procedures are performed in the clinic setting using local anesthesia, aiming to compare feasibility, tolerability, and diagnostic adequacy with traditional operating room approaches. The study collects patient-reported satisfaction and survey responses alongside procedural data. Eligible participants have a history or suspected UTUC and are planned for office-based ureteroscopic assessment, with follow-up assessments to gauge tolerability and potential benefits. No phase designation is provided for this non-traditional setting study.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan Rogel Cancer Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Khurshid Ghani, MD — University of Michigan Rogel Cancer Center
• Study coordinator: Michael Uy, MD
• Email: Uymichae@med.umich.edu
• Phone: 734-936-7030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.