Recruiting

Ureteroscopy

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07630155

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Analgesic Agent

Electronic Health Record Review

Lidocaine Topical

Medical Device Usage and Evaluation

Survey Administration

Study Details

Brief summary:

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.

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

Study ID

NCT07630155

Start date

Dec, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Analgesic Agent

Given PO

Electronic Health Record Review

Ancillary studies

Lidocaine Topical

Given intraurethrally

Medical Device Usage and Evaluation

Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope

Survey Administration

Ancillary studies

Ureteroscopy

Undergo ureteroscopy

Primary outcome measure

  • Success rate [ Time Frame: On day of procedure ]

Central Contacts and Locations

Central contacts

Michael Uy, MD

734-936-7030Uymichae@med.umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Michael Uy, MD

734-936-7030Uymichae@med.umich.edu

Principal Investigator:

Khurshid Ghani, MD

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.