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Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis (EASILY)

Primary Purpose

Lithiasis, Urinary

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ILY robotic flexible ureteroscopy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lithiasis, Urinary

Eligibility Criteria

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

Inclusion Criteria:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old
  • The patient has a single kidney stone in the calyx or the pelvis between 5 and 15mm something to do with a JJ probe
  • Patient has an indication for in situ lithotripsy by supply ureteroscopy

Exclusion Criteria:

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The patient is under safeguard of justice or state guardianship
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is pregnant or breastfeeding
  • Patient treated with anticoagulants
  • Documented untreated urinary infection within the previous 48 hours

Sites / Locations

  • CHU Nimes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

flexible ureteroscopy

Arm Description

Outcomes

Primary Outcome Measures

Number of procedures performed entirely using the telemanipulator
Number of procedures where the surgeon had to switch to manual mode or dedock the device
If telemanipulator remained stable during procedure
Yes/no
Time of procedure
Docking time
time between docking of device and use of gamepad
Time taken to track kidney stones
Time taken for complete exploration of renal cavities
Laser fragmentation time
Speed of fragmentation
mm3/minute
Any joint pain strain experienced by the surgeon before and after intervention
binary yes/no
Satisfaction of surgeon in using the device
Custom-made questionnaire with 3 sections measuring: ease of use, ergonomics in exploration of renal cavities and stability during fragmentation of laser

Secondary Outcome Measures

Describe the rate of intra-operative complications during procedure
Describe the rate of intra-operative complications
Integrity of the ureroscope at the end of the procedure
binary yes/no

Full Information

First Posted
August 16, 2018
Last Updated
August 3, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03638336
Brief Title
Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis
Acronym
EASILY
Official Title
Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis in the Upper Urinary Tract
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No actual DM
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this pilot study, we wish to evaluate the performance of a robotic flexible ureteorscopy (ILY) in the treatment of nephrolithiasis in the superior excretory system

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lithiasis, Urinary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flexible ureteroscopy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ILY robotic flexible ureteroscopy
Intervention Description
fragmentation of nephrolithiasis
Primary Outcome Measure Information:
Title
Number of procedures performed entirely using the telemanipulator
Time Frame
end of study: 3 months
Title
Number of procedures where the surgeon had to switch to manual mode or dedock the device
Time Frame
end of study: 3 months
Title
If telemanipulator remained stable during procedure
Description
Yes/no
Time Frame
end of procedure; less than 2 hours
Title
Time of procedure
Time Frame
end of procedure; less than 2 hours
Title
Docking time
Description
time between docking of device and use of gamepad
Time Frame
end of procedure; less than 2 hours
Title
Time taken to track kidney stones
Time Frame
end of procedure; less than 2 hours
Title
Time taken for complete exploration of renal cavities
Time Frame
end of procedure; less than 2 hours
Title
Laser fragmentation time
Time Frame
end of procedure; less than 2 hours
Title
Speed of fragmentation
Description
mm3/minute
Time Frame
end of procedure; less than 2 hours
Title
Any joint pain strain experienced by the surgeon before and after intervention
Description
binary yes/no
Time Frame
end of procedure; less than 2 hours
Title
Satisfaction of surgeon in using the device
Description
Custom-made questionnaire with 3 sections measuring: ease of use, ergonomics in exploration of renal cavities and stability during fragmentation of laser
Time Frame
end of procedure; less than 2 hours
Secondary Outcome Measure Information:
Title
Describe the rate of intra-operative complications during procedure
Time Frame
end of procedure; less than 2 hours
Title
Describe the rate of intra-operative complications
Time Frame
1 month
Title
Integrity of the ureroscope at the end of the procedure
Description
binary yes/no
Time Frame
end of procedure; less than 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient must have given their free and informed consent and signed the consent form The patient must be a member or beneficiary of a health insurance plan The patient is at least 18 years old The patient has a single kidney stone in the calyx or the pelvis between 5 and 15mm something to do with a JJ probe Patient has an indication for in situ lithotripsy by supply ureteroscopy Exclusion Criteria: The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study The patient is under safeguard of justice or state guardianship The subject refuses to sign the consent It is impossible to give the subject informed information The patient is pregnant or breastfeeding Patient treated with anticoagulants Documented untreated urinary infection within the previous 48 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Droupy
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis

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