Clinical trial NCT05646069: Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
Official title: Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: UTI
Stone, Kidney
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Males and Females 18-89 undergoing ureteroscopy for laser treatment of renal calculi
* Willing to sign the Informed Consent Form
* Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.

Exclusion Criteria:

* Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL)
* Pregnancy

Primary outcomes:
measure: Scope performance
timeFrame: 0-1 day
Secondary outcomes:
measure: Operating room outcomes
timeFrame: 0-1 day
measure: Operating room outcomes
timeFrame: 0-1 day
measure: Operating room outcomes
timeFrame: 0-1 day
measure: Operating room outcomes
timeFrame: 0-1 day
measure: Operating room outcomes
timeFrame: 0-1 day
measure: Post-operative outcomes
timeFrame: 4-6 weeks
measure: Post-operative outcomes
timeFrame: 4-6 weeks
measure: Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)
timeFrame: 4-6 weeks
measure: Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)
timeFrame: 4-6 weeks
measure: Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference
timeFrame: 4-6 weeks
measure: Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference
timeFrame: 4-6 weeks
measure: Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view
timeFrame: 4-6 weeks
measure: Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: