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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Pelvis and Ureter Urothelial Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Drug: Analgesic Agent; Drug: Lidocaine Topical; Device: Medical Device Usage and Evaluation; Procedure: Ureteroscopy

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Uy, MD; Phone Number: 734-936-7030; Email: Uymichae@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center
      • Principal Investigator: Khurshid Ghani, MD
      • Contact: Michael Uy, MD; Phone Number: 734-936-7030; Email: Uymichae@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Drug: Analgesic Agent; Given PO; Other Names: Analgesics; analgesic; Analgesic Drugs; Anodynes; Antinociceptive Agents; Pain-relief Medication; Drug: Lidocaine Topical; Given intraurethrally; Device: Medical Device Usage and Evaluation; Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope; Procedure: Ureteroscopy; Undergo ureteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	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.	On day of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Assessed by intra- and peri-procedure patient reported outcomes with the visual analogue scale pain score, as well as the Patient-Reported Outcomes Measurement Information System Pain Interference and Intensity score. Will be summarized and displayed graphically with means, standard deviations and/or quartiles.	From baseline up to 7-10 days post procedure
Satisfaction	Assessed by the International Consultation on Incontinence-Satisfaction. Will be summarized and displayed graphically with means, standard deviations and/or quartiles.	At 7-10 days post procedure
Unplanned healthcare use	Will measure unplanned healthcare utilization including electronic messages, phone calls, lab and imaging tests, emergency department visits, hospitalizations, and secondary interventions. These will be reported as counts of events and counts of participants with corresponding proportions of enrolled participants.	From baseline up to 30 days post procedure

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: Shenzhen HugeMed Medical Technical Development
• Investigators: Principal Investigator: Khurshid Ghani, MD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 18, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Organic Chemicals; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Diagnostic Techniques, Surgical; Endoscopy; Urologic Surgical Procedures; Urogenital Surgical Procedures; Central Nervous System Agents; Diagnostic Techniques, Urological; Acetaminophen; Lidocaine; Analgesics; Ureteroscopy; Physical Examination
• Other Study ID Numbers: UMCC 2025.155; NCI-2026-03864 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00284243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes