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NCT Number: NCT05646069

Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi

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.

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Key information

Conditions

UTI Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stone, Kidney Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Storz Flex-XC1 Disposable Flexible Ureteroscope

Device

Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.

Storz Flexible Digital Ureteroscope

Device

Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.

Primary outcomes

  1. Scope performance

    Time frame: 0-1 day

    Difference in scope performance grading by multiple blinded reviewers

Secondary outcomes

  1. Operating room outcomes

    Time frame: 0-1 day

    The difference in operating room outcomes: basketing time

  2. Operating room outcomes

    Time frame: 0-1 day

    The difference in operating room outcomes: scope setup time

  3. Operating room outcomes

    Time frame: 0-1 day

    The difference in operating room outcomes: laser-use time

  4. Operating room outcomes

    Time frame: 0-1 day

    The difference in operating room outcomes: operative time

  5. Operating room outcomes

    Time frame: 0-1 day

    The difference in operating room outcomes: number of flexible ureteroscopes used

  6. Post-operative outcomes

    Time frame: 4-6 weeks

    The difference in postoperative outcomes using a questionnaire: the patient has a UTI

  7. Post-operative outcomes

    Time frame: 4-6 weeks

    The difference in postoperative outcomes using a questionnaire: the patient is stone-free

  8. Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)

    Time frame: 4-6 weeks

    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)

  9. Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)

    Time frame: 4-6 weeks

    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)

  10. Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference

    Time frame: 4-6 weeks

    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)

  11. Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference

    Time frame: 4-6 weeks

    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)

  12. Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view

    Time frame: 4-6 weeks

    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)

  13. Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression

    Time frame: 4-6 weeks

    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)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 12, 2022
Registry last updated
Jun 27, 2024

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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