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

NCT ID: NCT03638336

Last Updated: 2020-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2020-01-31

Brief Summary

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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

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Conditions

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Lithiasis, Urinary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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flexible ureteroscopy

Group Type EXPERIMENTAL

ILY robotic flexible ureteroscopy

Intervention Type DEVICE

fragmentation of nephrolithiasis

Interventions

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ILY robotic flexible ureteroscopy

fragmentation of nephrolithiasis

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane Droupy

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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IDIL/2016/SD-01

Identifier Type: -

Identifier Source: org_study_id

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