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

Not Applicable

Withdrawn

• Conditions: Lithiasis, Urinary

• Registration Number: NCT03638336
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Study Start: 2018-10
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
If telemanipulator remained stable during procedure	end of procedure; less than 2 hours	Yes/no
Time taken to track kidney stones	end of procedure; less than 2 hours
Number of procedures where the surgeon had to switch to manual mode or dedock the device	end of study: 3 months
Time taken for complete exploration of renal cavities	end of procedure; less than 2 hours
Docking time	end of procedure; less than 2 hours	time between docking of device and use of gamepad
Laser fragmentation time	end of procedure; less than 2 hours
Number of procedures performed entirely using the telemanipulator	end of study: 3 months
Speed of fragmentation	end of procedure; less than 2 hours	mm3/minute
Satisfaction of surgeon in using the device	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
Time of procedure	end of procedure; less than 2 hours
Any joint pain strain experienced by the surgeon before and after intervention	end of procedure; less than 2 hours	binary yes/no

Secondary Outcome Measures

Name	Time	Method
Describe the rate of intra-operative complications during procedure	end of procedure; less than 2 hours
Integrity of the ureroscope at the end of the procedure	end of procedure; less than 2 hours	binary yes/no
Describe the rate of intra-operative complications	1 month

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France