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

August 3, 2020 updated by: Centre Hospitalier Universitaire de Nīmes

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • France
      • Nîmes, France, 30029
        • Chu Nimes

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: flexible ureteroscopy
Device: ILY robotic flexible ureteroscopy
fragmentation of nephrolithiasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of procedures performed entirely using the telemanipulator
Time Frame: end of study: 3 months
end of study: 3 months
Number of procedures where the surgeon had to switch to manual mode or dedock the device
Time Frame: end of study: 3 months
end of study: 3 months
If telemanipulator remained stable during procedure
Time Frame: end of procedure; less than 2 hours
Yes/no
end of procedure; less than 2 hours
Time of procedure
Time Frame: end of procedure; less than 2 hours
end of procedure; less than 2 hours
Docking time
Time Frame: end of procedure; less than 2 hours
time between docking of device and use of gamepad
end of procedure; less than 2 hours
Time taken to track kidney stones
Time Frame: end of procedure; less than 2 hours
end of procedure; less than 2 hours
Time taken for complete exploration of renal cavities
Time Frame: end of procedure; less than 2 hours
end of procedure; less than 2 hours
Laser fragmentation time
Time Frame: end of procedure; less than 2 hours
end of procedure; less than 2 hours
Speed of fragmentation
Time Frame: end of procedure; less than 2 hours
mm3/minute
end of procedure; less than 2 hours
Any joint pain strain experienced by the surgeon before and after intervention
Time Frame: end of procedure; less than 2 hours
binary yes/no
end of procedure; less than 2 hours
Satisfaction of surgeon in using the device
Time Frame: end of procedure; less than 2 hours
Custom-made questionnaire with 3 sections measuring: ease of use, ergonomics in exploration of renal cavities and stability during fragmentation of laser
end of procedure; less than 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the rate of intra-operative complications during procedure
Time Frame: end of procedure; less than 2 hours
end of procedure; less than 2 hours
Describe the rate of intra-operative complications
Time Frame: 1 month
1 month
Integrity of the ureroscope at the end of the procedure
Time Frame: end of procedure; less than 2 hours
binary yes/no
end of procedure; less than 2 hours

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Stéphane Droupy, Chu Nimes

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 (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDIL/2016/SD-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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