An interventional study of Analgesic Agent and Electronic Health Record Review in Renal Pelvis and Ureter Urothelial Carcinoma, sponsored by University of Michigan Rogel Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Diagnostic
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.
University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Given PO
Also known as: analgesic, Analgesic Drugs, Analgesics, Anodynes, Antinociceptive Agents, Pain-relief Medication
Ancillary studies
Given intraurethrally
Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope
Ancillary studies
Undergo ureteroscopy
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.
Time frame: On day of procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline up to 30 days post procedure
Plan to share: No
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University of Michigan Rogel Cancer Center