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

June 26, 2024 updated by: Amy Krambeck, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Storz Flex-XC1 disposable flexible ureteroscope
A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
Device: Storz Flex-XC1 Disposable Flexible Ureteroscope
Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
No Intervention: Analogue scope
A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
Experimental: Digital ureteroscope
A patient is randomized to the experimental arm using a Digital ureteroscope.
Device: Storz Flexible Digital Ureteroscope
Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scope performance
Time Frame: 0-1 day
Difference in scope performance grading by multiple blinded reviewers
0-1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating room outcomes
Time Frame: 0-1 day
The difference in operating room outcomes: basketing time
0-1 day
Operating room outcomes
Time Frame: 0-1 day
The difference in operating room outcomes: scope setup time
0-1 day
Operating room outcomes
Time Frame: 0-1 day
The difference in operating room outcomes: laser-use time
0-1 day
Operating room outcomes
Time Frame: 0-1 day
The difference in operating room outcomes: operative time
0-1 day
Operating room outcomes
Time Frame: 0-1 day
The difference in operating room outcomes: number of flexible ureteroscopes used
0-1 day
Post-operative outcomes
Time Frame: 4-6 weeks
The difference in postoperative outcomes using a questionnaire: the patient has a UTI
4-6 weeks
Post-operative outcomes
Time Frame: 4-6 weeks
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)
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)
4-6 weeks
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)
4-6 weeks
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)
4-6 weeks
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)
4-6 weeks
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)
4-6 weeks
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)
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

December 2, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00217933

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stone, Kidney

Clinical Trials on Storz Flex-XC1 Disposable Flexible Ureteroscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe