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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03638336
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 0

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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
• Anticipated Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of procedures performed entirely using the telemanipulator [end of study: 3 months]

2. Number of procedures where the surgeon had to switch to manual mode or dedock the device [end of study: 3 months]

3. If telemanipulator remained stable during procedure [end of procedure; less than 2 hours]

   Yes/no

4. Time of procedure [end of procedure; less than 2 hours]

5. Docking time [end of procedure; less than 2 hours]

   time between docking of device and use of gamepad

6. Time taken to track kidney stones [end of procedure; less than 2 hours]

7. Time taken for complete exploration of renal cavities [end of procedure; less than 2 hours]

8. Laser fragmentation time [end of procedure; less than 2 hours]

9. Speed of fragmentation [end of procedure; less than 2 hours]

   mm3/minute

10. Any joint pain strain experienced by the surgeon before and after intervention [end of procedure; less than 2 hours]

    binary yes/no

11. 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

Secondary Outcome Measures

1. Describe the rate of intra-operative complications during procedure [end of procedure; less than 2 hours]

2. Describe the rate of intra-operative complications [1 month]

3. Integrity of the ureroscope at the end of the procedure [end of procedure; less than 2 hours]

   binary yes/no

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CHU Nimes	Nîmes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Stéphane Droupy, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT03638336
• Other Study ID Numbers: IDIL/2016/SD-01
• First Posted: Aug 20, 2018
• Last Update Posted: Aug 5, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nephrolithiasis; Kidney Calculi; Urolithiasis; Urinary Calculi; Lithiasis

Study Results

No Results Posted as of Aug 5, 2020