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

NCT03638336 | Withdrawn

• 1 other identifier: IDIL/2016/SD-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Lithiasis, Urinary

Outcome Measures

Primary Outcomes (11)

• Number of procedures performed entirely using the telemanipulator

  end of study: 3 months

• Number of procedures where the surgeon had to switch to manual mode or dedock the device

  end of study: 3 months

• If telemanipulator remained stable during procedure

  Yes/no

  end of procedure; less than 2 hours

• Time of procedure

  end of procedure; less than 2 hours

• Docking time

  time between docking of device and use of gamepad

  end of procedure; less than 2 hours

• Time taken to track kidney stones

  end of procedure; less than 2 hours

• Time taken for complete exploration of renal cavities

  end of procedure; less than 2 hours

• Laser fragmentation time

  end of procedure; less than 2 hours

• Speed of fragmentation

  mm3/minute

  end of procedure; less than 2 hours

• Any joint pain strain experienced by the surgeon before and after intervention

  binary yes/no

  end of procedure; less than 2 hours

• 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 Outcomes (3)

• Describe the rate of intra-operative complications during procedure

  end of procedure; less than 2 hours

• Describe the rate of intra-operative complications

  1 month

• Integrity of the ureroscope at the end of the procedure

  end of procedure; less than 2 hours

Study Arms (1)

flexible ureteroscopy

EXPERIMENTAL

Device: ILY robotic flexible ureteroscopy

Interventions

ILY robotic flexible ureteroscopy DEVICE

fragmentation of nephrolithiasis

flexible ureteroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Stéphane Droupy

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: October 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)