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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-03864 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HUM00284243 |
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| Name | Class |
|---|---|
| Shenzhen HugeMed Medical Technical Development | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analgesic Agent | Drug | Given PO |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Uy, MD | Contact | 734-936-7030 | Uymichae@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Khurshid Ghani, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Lidocaine Topical | Drug | Given intraurethrally |
|
| Medical Device Usage and Evaluation | Device | Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope |
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| Survey Administration | Other | Ancillary studies |
|
| Ureteroscopy | Procedure | Undergo ureteroscopy |
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| 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 |
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000700 | Analgesics |
| D008012 | Lidocaine |
| D010808 | Physical Examination |
| D018666 | Ureteroscopy |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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