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

Lithiasis, Urinary Clinical Trial

— EASILY  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03638336
• Other study ID #: IDIL/2016/SD-01
• Status: Withdrawn
• Phase: N/A
• Start date: October 2018
• Est. completion date: January 2020

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Lithiasis
• Lithiasis, Urinary
• Nephrolithiasis
• Urolithiasis

Intervention

Device:
• ILY robotic flexible ureteroscopy
fragmentation of nephrolithiasis

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of procedures performed entirely using the telemanipulator		end of study: 3 months
Primary	Number of procedures where the surgeon had to switch to manual mode or dedock the device		end of study: 3 months
Primary	If telemanipulator remained stable during procedure	Yes/no	end of procedure; less than 2 hours
Primary	Time of procedure		end of procedure; less than 2 hours
Primary	Docking time	time between docking of device and use of gamepad	end of procedure; less than 2 hours
Primary	Time taken to track kidney stones		end of procedure; less than 2 hours
Primary	Time taken for complete exploration of renal cavities		end of procedure; less than 2 hours
Primary	Laser fragmentation time		end of procedure; less than 2 hours
Primary	Speed of fragmentation	mm3/minute	end of procedure; less than 2 hours
Primary	Any joint pain strain experienced by the surgeon before and after intervention	binary yes/no	end of procedure; less than 2 hours
Primary	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	end of procedure; less than 2 hours
Secondary	Describe the rate of intra-operative complications during procedure		end of procedure; less than 2 hours
Secondary	Describe the rate of intra-operative complications		1 month
Secondary	Integrity of the ureroscope at the end of the procedure	binary yes/no	end of procedure; less than 2 hours