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

NCT07630155 | Not Yet Recruiting FDA Device

• 3 other identifiers: UMCC 2025.155NCI-2026-03864HUM00284243
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain

  From baseline up to 7-10 days post procedure

• Satisfaction

  At 7-10 days post procedure

• Unplanned healthcare use

  From baseline up to 30 days post procedure

Study Arms (1)

Diagnostic (in office ureteroscopy)

EXPERIMENTAL

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.

Drug: Analgesic Agent; Other: Electronic Health Record Review; Drug: Lidocaine Topical; Device: Medical Device Usage and Evaluation; Other: Survey Administration; Procedure: Ureteroscopy

Interventions

Analgesic Agent DRUG

Given PO

Also known as: analgesic, Analgesic Drugs, Analgesics, Anodynes, Antinociceptive Agents, Pain-relief Medication

Diagnostic (in office ureteroscopy)

Electronic Health Record Review OTHER

Ancillary studies

Diagnostic (in office ureteroscopy)

Lidocaine Topical DRUG

Given intraurethrally

Diagnostic (in office ureteroscopy)

Medical Device Usage and Evaluation DEVICE

Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope

Diagnostic (in office ureteroscopy)

Survey Administration OTHER

Ancillary studies

Diagnostic (in office ureteroscopy)

Ureteroscopy PROCEDURE

Undergo ureteroscopy

Diagnostic (in office ureteroscopy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen HugeMed Medical Technical Development: collaborator
• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Acetaminophen; Analgesics; Lidocaine; Physical Examination; Ureteroscopy

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Khurshid Ghani, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Uy, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 18, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)