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NCT Number: NCT07630155

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

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.

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Key information

Conditions

Renal Pelvis and Ureter Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Khurshid Ghani, MD

PRINCIPAL_INVESTIGATOR

Michael Uy, MD

CONTACT

[email protected]

734-936-7030

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analgesic Agent

Drug

Given PO

Other names: analgesic, Analgesic Drugs, Analgesics, Anodynes, Antinociceptive Agents, Pain-relief Medication

Electronic Health Record Review

Other

Ancillary studies

Lidocaine topical

Drug

Given intraurethrally

Medical Device Usage and Evaluation

Device

Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope

Survey Administration

Other

Ancillary studies

Ureteroscopy

Procedure

Undergo ureteroscopy

Primary outcomes

  1. Success rate

    Time frame: On 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.

Secondary outcomes

  1. Pain

    Time frame: From baseline up to 7-10 days post procedure

    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.

  2. Satisfaction

    Time frame: At 7-10 days post procedure

    Assessed by the International Consultation on Incontinence-Satisfaction. Will be summarized and displayed graphically with means, standard deviations and/or quartiles.

  3. Unplanned healthcare use

    Time frame: From baseline up to 30 days post procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Uy, MD

CONTACT

[email protected]

734-936-7030

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • Shenzhen HugeMed Medical Technical Development

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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