Lithiasis, UrinaryEASILYNCT03638336
Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis
A study testing ILY robotic flexible ureteroscopy in people with Lithiasis, Urinary, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lithiasis, Urinary
- What is being tested?
- ILY robotic flexible ureteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2018to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis in the Upper Urinary Tract
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
- Being tested
- ILY robotic flexible ureteroscopy
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILY robotic flexible ureteroscopyDevice
fragmentation of nephrolithiasis
| Study group | Role | What they receive |
|---|---|---|
| flexible ureteroscopy | Experimental | Not described Receives: Device: ILY robotic flexible ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of procedures performed entirely using the telemanipulator
Measured: end of study: 3 months
Number of procedures where the surgeon had to switch to manual mode or dedock the device
Measured: end of study: 3 months
If telemanipulator remained stable during procedure
Yes/no
Measured: end of procedure; less than 2 hours
Time of procedure
Measured: end of procedure; less than 2 hours
Docking time
time between docking of device and use of gamepad
Measured: end of procedure; less than 2 hours
Time taken to track kidney stones
Measured: end of procedure; less than 2 hours
Time taken for complete exploration of renal cavities
Measured: end of procedure; less than 2 hours
Laser fragmentation time
Measured: end of procedure; less than 2 hours
Speed of fragmentation
mm3/minute
Measured: end of procedure; less than 2 hours
Any joint pain strain experienced by the surgeon before and after intervention
binary yes/no
Measured: 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
Measured: end of procedure; less than 2 hours
Secondary outcomes (3)
Describe the rate of intra-operative complications during procedure
Measured: end of procedure; less than 2 hours
Describe the rate of intra-operative complications
Measured: 1 month
Integrity of the ureroscope at the end of the procedure
binary yes/no
Measured: end of procedure; less than 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: No actual DM
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lithiasis, UrinaryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Droupy, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638336
- Sponsor's protocol ID
- IDIL/2016/SD-01
- Acronym
- EASILY
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2018
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of a Robotic Flexible Ureteroscopy (ILY) in Laser Treatment of Nephrolithiasis in the Upper Urinary Tract
- ClinicalTrials.gov ID
- NCT03638336
- Acronym / sponsor ID
- EASILY / IDIL/2016/SD-01
- Conditions
- Lithiasis, Urinary
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No actual DM
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flexible ureteroscopy | Experimental | Device: ILY robotic flexible ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILY robotic flexible ureteroscopyfragmentation of nephrolithiasis | Device | flexible ureteroscopy |
Primary outcome
Number of procedures performed entirely using the telemanipulator
Time frame: end of study: 3 months
Number of procedures where the surgeon had to switch to manual mode or dedock the device
Time frame: end of study: 3 months
If telemanipulator remained stable during procedure
Time frame: end of procedure; less than 2 hours
Yes/no
Time of procedure
Time frame: end of procedure; less than 2 hours
Docking time
Time frame: end of procedure; less than 2 hours
time between docking of device and use of gamepad
Time taken to track kidney stones
Time frame: end of procedure; less than 2 hours
Time taken for complete exploration of renal cavities
Time frame: end of procedure; less than 2 hours
Laser fragmentation time
Time frame: end of procedure; less than 2 hours
Speed of fragmentation
Time frame: end of procedure; less than 2 hours
mm3/minute
Any joint pain strain experienced by the surgeon before and after intervention
Time frame: end of procedure; less than 2 hours
binary yes/no
Satisfaction of surgeon in using the device
Time frame: 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
3 secondary outcomes
Describe the rate of intra-operative complications during procedure
Time frame: end of procedure; less than 2 hours
Describe the rate of intra-operative complications
Time frame: 1 month
Integrity of the ureroscope at the end of the procedure
Time frame: end of procedure; less than 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Droupy principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ILY robotic flexible ureteroscopy in people with Lithiasis, Urinary, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of procedures performed entirely using the telemanipulator (time frame: end of study: 3 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.