Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to provide an evaluation of currently available disposable flexible ureteroscopes in real-world conditions. Due to high re-processing costs associated with re-usable flexible ureteroscopes, there has been a demand for Urologic device manufacturers to provide single-use flexible ureteroscopes.
Patients randomized to the experimental group will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
Data will be collected and stored electronically in REDCap. Quality assurance steps will include testing of the database, including any potential data calculated by command functions within REDCap
Scope performance survey will be administered with REDcap.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Storz Flex-XC1 disposable flexible ureteroscope | Experimental | A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope. |
|
| Analogue scope | No Intervention | A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope. | |
| Digital ureteroscope | Experimental | A patient is randomized to the experimental arm using a Digital ureteroscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Storz Flex-XC1 Disposable Flexible Ureteroscope | Device | Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scope performance | Difference in scope performance grading by multiple blinded reviewers | 0-1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Operating room outcomes | The difference in operating room outcomes: basketing time | 0-1 day |
| Operating room outcomes | The difference in operating room outcomes: scope setup time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39937281 | Derived | Wong C, Xu P, Dean N, Assmus M, McDonald A, Agarwal D, Ali S, Abedi G, Margolin E, Medairos R, Nottingham C, Krambeck A. A prospective survey evaluating the visual quality of KARL STORZ fiberoptic, digital, and disposable flexible ureteroscopes. World J Urol. 2025 Feb 12;43(1):119. doi: 10.1007/s00345-025-05502-x. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Assignment
Not provided
Not provided
Not provided
Not provided
| Storz Flexible Digital Ureteroscope | Device | Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope. |
|
| 0-1 day |
| Operating room outcomes | The difference in operating room outcomes: laser-use time | 0-1 day |
| Operating room outcomes | The difference in operating room outcomes: operative time | 0-1 day |
| Operating room outcomes | The difference in operating room outcomes: number of flexible ureteroscopes used | 0-1 day |
| Post-operative outcomes | The difference in postoperative outcomes using a questionnaire: the patient has a UTI | 4-6 weeks |
| Post-operative outcomes | The difference in postoperative outcomes using a questionnaire: the patient is stone-free | 4-6 weeks |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution) | Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5) | 4-6 weeks |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color) | Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5) | 4-6 weeks |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference | Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5) | 4-6 weeks |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference | Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5) | 4-6 weeks |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view | Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5) | 4-6 weeks |
| Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression | Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5) | 4-6 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |