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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03638336
Recruitment Status : Withdrawn (No actual DM)
First Posted : August 20, 2018
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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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

Condition or disease Intervention/treatment Phase
Lithiasis, Urinary Device: ILY robotic flexible ureteroscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis in the Upper Urinary Tract
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arms and Interventions
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Arm Intervention/treatment
Experimental: flexible ureteroscopy Device: ILY robotic flexible ureteroscopy
fragmentation of nephrolithiasis


Outcome Measures
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Primary Outcome Measures :
  1. Number of procedures performed entirely using the telemanipulator [ Time Frame: end of study: 3 months ]
  2. Number of procedures where the surgeon had to switch to manual mode or dedock the device [ Time Frame: end of study: 3 months ]
  3. If telemanipulator remained stable during procedure [ Time Frame: end of procedure; less than 2 hours ]
    Yes/no

  4. Time of procedure [ Time Frame: end of procedure; less than 2 hours ]
  5. Docking time [ Time Frame: end of procedure; less than 2 hours ]
    time between docking of device and use of gamepad

  6. Time taken to track kidney stones [ Time Frame: end of procedure; less than 2 hours ]
  7. Time taken for complete exploration of renal cavities [ Time Frame: end of procedure; less than 2 hours ]
  8. Laser fragmentation time [ Time Frame: end of procedure; less than 2 hours ]
  9. Speed of fragmentation [ Time Frame: end of procedure; less than 2 hours ]
    mm3/minute

  10. Any joint pain strain experienced by the surgeon before and after intervention [ Time Frame: end of procedure; less than 2 hours ]
    binary yes/no

  11. 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


Secondary Outcome Measures :
  1. Describe the rate of intra-operative complications during procedure [ Time Frame: end of procedure; less than 2 hours ]
  2. Describe the rate of intra-operative complications [ Time Frame: 1 month ]
  3. Integrity of the ureroscope at the end of the procedure [ Time Frame: end of procedure; less than 2 hours ]
    binary yes/no


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03638336


Locations
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France
CHU Nimes
Nîmes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Stéphane Droupy CHU Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03638336    
Other Study ID Numbers: IDIL/2016/SD-01
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Urolithiasis
Urinary Calculi
Lithiasis
 Kidney Diseases
Urologic Diseases
Calculi
Pathological Conditions, Anatomical
Pathologic Processes