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

Primary Purpose

UTI, Stone, Kidney

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Storz Flex-XC1 Disposable Flexible Ureteroscope
Storz Flexible Digital Ureteroscope
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for UTI

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Storz Flex-XC1 disposable flexible ureteroscope

Analogue scope

Digital ureteroscope

Arm Description

A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.

A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.

A patient is randomized to the experimental arm using a Digital ureteroscope.

Outcomes

Primary Outcome Measures

Scope performance
Difference in scope performance grading by multiple blinded reviewers

Secondary Outcome Measures

Operating room outcomes
The difference in operating room outcomes: basketing time
Operating room outcomes
The difference in operating room outcomes: scope setup time
Operating room outcomes
The difference in operating room outcomes: laser-use time
Operating room outcomes
The difference in operating room outcomes: operative time
Operating room outcomes
The difference in operating room outcomes: number of flexible ureteroscopes used
Post-operative outcomes
The difference in postoperative outcomes using a questionnaire: the patient has a UTI
Post-operative outcomes
The difference in postoperative outcomes using a questionnaire: the patient is stone-free
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)
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)
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)
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)
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)
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)

Full Information

First Posted
November 18, 2022
Last Updated
October 2, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05646069
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
UTI, Stone, Kidney

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Storz Flex-XC1 disposable flexible ureteroscope
Arm Type
Experimental
Arm Description
A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
Arm Title
Analogue scope
Arm Type
No Intervention
Arm Description
A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
Arm Title
Digital ureteroscope
Arm Type
Experimental
Arm Description
A patient is randomized to the experimental arm using a Digital ureteroscope.
Intervention Type
Device
Intervention Name(s)
Storz Flex-XC1 Disposable Flexible Ureteroscope
Intervention Description
Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
Intervention Type
Device
Intervention Name(s)
Storz Flexible Digital Ureteroscope
Intervention Description
Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.
Primary Outcome Measure Information:
Title
Scope performance
Description
Difference in scope performance grading by multiple blinded reviewers
Time Frame
0-1 day
Secondary Outcome Measure Information:
Title
Operating room outcomes
Description
The difference in operating room outcomes: basketing time
Time Frame
0-1 day
Title
Operating room outcomes
Description
The difference in operating room outcomes: scope setup time
Time Frame
0-1 day
Title
Operating room outcomes
Description
The difference in operating room outcomes: laser-use time
Time Frame
0-1 day
Title
Operating room outcomes
Description
The difference in operating room outcomes: operative time
Time Frame
0-1 day
Title
Operating room outcomes
Description
The difference in operating room outcomes: number of flexible ureteroscopes used
Time Frame
0-1 day
Title
Post-operative outcomes
Description
The difference in postoperative outcomes using a questionnaire: the patient has a UTI
Time Frame
4-6 weeks
Title
Post-operative outcomes
Description
The difference in postoperative outcomes using a questionnaire: the patient is stone-free
Time Frame
4-6 weeks
Title
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)
Description
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)
Time Frame
4-6 weeks
Title
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)
Description
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)
Time Frame
4-6 weeks
Title
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference
Description
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)
Time Frame
4-6 weeks
Title
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference
Description
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)
Time Frame
4-6 weeks
Title
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view
Description
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)
Time Frame
4-6 weeks
Title
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression
Description
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)
Time Frame
4-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chioma Anyanti, MS
Phone
3126958146
Ext
44591
Email
Chioma.Anyanti@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Krambeck, MD
Phone
3126958146
Email
Amy.Krambeck@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa McDonald
Phone
312-695-8146
Email
alyssa.mcdonald@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Allaa Fadl-Alla
Phone
3126958146
Email
allaa.fadlalla@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Amy Krambeck, MD

12. IPD Sharing Statement

Learn more about this trial

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

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