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

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

Interventions

DRUG

Analgesic Agent

Given PO

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

Sponsors & Collaborators

• Shenzhen HugeMed Medical Technical Development

  collaborator UNKNOWN

• University of Michigan Rogel Cancer Center

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-08-31

Completion

2027-08-31

FDA Device

Yes

Countries

• United States

Study Locations