Clinical trial NCT03638336: Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis
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
Overall status: WITHDRAWN
Phase: NA
Conditions: Lithiasis, Urinary
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of procedures performed entirely using the telemanipulator
timeFrame: end of study: 3 months
measure: Number of procedures where the surgeon had to switch to manual mode or dedock the device
timeFrame: end of study: 3 months
measure: If telemanipulator remained stable during procedure
timeFrame: end of procedure; less than 2 hours
measure: Time of procedure
timeFrame: end of procedure; less than 2 hours
measure: Docking time
timeFrame: end of procedure; less than 2 hours
measure: Time taken to track kidney stones
timeFrame: end of procedure; less than 2 hours
measure: Time taken for complete exploration of renal cavities
timeFrame: end of procedure; less than 2 hours
measure: Laser fragmentation time
timeFrame: end of procedure; less than 2 hours
measure: Speed of fragmentation
timeFrame: end of procedure; less than 2 hours
measure: Any joint pain strain experienced by the surgeon before and after intervention
timeFrame: end of procedure; less than 2 hours
measure: Satisfaction of surgeon in using the device
timeFrame: end of procedure; less than 2 hours
Secondary outcomes:
measure: Describe the rate of intra-operative complications during procedure
timeFrame: end of procedure; less than 2 hours
measure: Describe the rate of intra-operative complications
timeFrame: 1 month
measure: Integrity of the ureroscope at the end of the procedure
timeFrame: end of procedure; less than 2 hours
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Stéphane Droupy
role: PRINCIPAL_INVESTIGATOR
References: