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Office-Based Ureteroscopy for Upper Tract Urothelial Carcinoma

This study is testing a new way to assess upper tract urothelial carcinoma (a type of cancer in the kidney or ureter, the tube connecting the kidney to the bladder). Traditionally, this assessment, called ureteroscopy (using a thin camera to look inside), is done in an operating room under general anesthesia. This study uses a very thin, single-use digital ureteroscope in the doctor's office, along with Lidocaine Topical (a numbing medicine) and an Analgesic Agent (pain medicine). Researchers will look at how well this office-based procedure works. You can join if you are 18 or older. The study aims to enroll 10 participants, and success is measured by how well the procedure works on the day it's performed.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It aims to enroll 10 participants.
What's involved
You would undergo a ureteroscopy procedure using a 6.3 Fr single-use digital ureteroscope, receive Lidocaine Topical and an Analgesic Agent, and complete surveys. Your electronic health records would also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, success rate, is measured on the day of the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07630155

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

Recruiting
NAAges 18+InterventionalDiagnostic
University of Michigan Rogel Cancer Center
~10 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Analgesic AgentElectronic Health Record ReviewLidocaine TopicalMedical Device Usage and EvaluationSurvey AdministrationUreteroscopy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Success rate
Measured over On day of procedure

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Khurshid Ghani, MD · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Michael Uy, MD
[email protected]
734-936-7030
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Success rateOn day of procedure

    Defined as the ability to successfully perform and complete upper and lower tract surveillance with the 6.3 French ureteroscope in an office setting. A study-wide successful outcome will be defined as a success rate of 70%. The success rate will be reported as the count and proportion of participants with a successful outcome out of the number of enrolled participants. The corresponding 95% binomial Clopper-Pearson confidence interval will be reported.