Kidney StonesNCT03087812
Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy
An observational study of Kidney Stones, run by Clinical Research Office of the Endourological Society at 1 site in Netherlands.
Trial summary
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 20 new ureteroscopes are usedfrom Olympus andfrom Storz) to study the durability of the ureteroscopes and the possible microbiological load. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stones
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2015to Dec 2017
- Phase
- Observational
- 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
Study population: The study population compromises those patients of over eighteen years old diagnosed to undergo a ureterorenoscopy (diagnostic or therapeutic) with a flexible ureterorenoscope.
Who may be able to join
- Patient presented with a diagnosis to undergo a ureterorenoscopy using a flexible ureterorenoscope
- over 18 years
- has signed informed consent
- the patient is being treated with the designated flexible ureterorenoscope
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 20 new ureteroscopes are usedfrom Olympus andfrom Storz) to study the durability of the ureteroscopes and the possible microbiological load.
Read the detailed description
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 6 new ureteroscopes are used (3 from Olympus and 3 from Storz) to study the durability of the ureteroscopes and the possible microbiological load.
Before the procedure is started the endoscope is tested for its microbiological load in two different ways:1. Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.
After the procedure is finished, the endoscope is tested for its microbiological load in two different ways:
- Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.
Transfer all samples to the lab as soon as possible but at least within four hours after collecting the samples.
As for the clinical efficacy during each procedure a detailed questionnaire about the use of each ureteroscope is filled out. This includes the ease of use making mention on quality of the image, torque, flexibility and durability.
Data will be collected through electronic case report forms (eCFRs), with use of an online Data Management system (DMS).
- Conditions
- Kidney Stones
- Keywords
- Microbiological burden, kidney, stone, durability of flexible endoscopes
- Medical subject headings
- Kidney Calculi, Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological load
To evaluate the pre-operative microbiological load of the tip and the working channel of the most common used flexible ureteroscopes, after high level disinfection
Measured: 2 years
Secondary outcomes (2)
Durability
To evaluate the durability of the most common used flexible ureteroscopes in terms of number of procedures, total use time and total degrees of flexibility loss until the first repair is needed.
Measured: 2 years
Factors affecting durability
To evaluate descriptive data on factors that may affect the durability of the flexible ureteroscopes. Factors measured are treatment time, treatment indication and anatomical location in the urinary tract, method of ureteroscope insertion number and type of accessory instrumentation through the working channel, difference in users, number of forcing the scope during the procedure and the number of disinfections.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study startDec 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Office of the Endourological Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean de la Rosette, MD, PhD, Study chair, Clinical Research Office of the Endourological Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087812
- Sponsor's protocol ID
- NL201501
- Status last verified
- Apr 2018
- First submitted
- 19 Nov 2015
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durability of Flexible Ureteroscopes and Causes of Infection During Flexible Ureterorenoscopy
- ClinicalTrials.gov ID
- NCT03087812
- Acronym / sponsor ID
- NL201501
- Conditions
- Kidney Stones
- Keywords
- Microbiological burden, kidney, stone, durability of flexible endoscopes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Clinical Research Office of the Endourological SocietyUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Mar 2017 (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.
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 20 new ureteroscopes are usedfrom Olympus andfrom Storz) to study the durability of the ureteroscopes and the possible microbiological load.
Detailed description
This is an observational study in which data on consecutive patients who undergo ureterorenoscopy with the use of a flexible ureterorenoscope are collected. In total 6 new ureteroscopes are used (3 from Olympus and 3 from Storz) to study the durability of the ureteroscopes and the possible microbiological load.
Before the procedure is started the endoscope is tested for its microbiological load in two different ways:1. Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.
After the procedure is finished, the endoscope is tested for its microbiological load in two different ways:
- Shake the tip of the flexible ureterorenoscope 5 seconds in a sterile container filled with 10 cc of NaCl 0.9% 2. Flush the working channel of the ureterorenoscope with 10 cc of NaCl 0.9% and collect the sample in a sterile container.
Transfer all samples to the lab as soon as possible but at least within four hours after collecting the samples.
As for the clinical efficacy during each procedure a detailed questionnaire about the use of each ureteroscope is filled out. This includes the ease of use making mention on quality of the image, torque, flexibility and durability.
Data will be collected through electronic case report forms (eCFRs), with use of an online Data Management system (DMS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population compromises those patients of over eighteen years old diagnosed to undergo a ureterorenoscopy (diagnostic or therapeutic) with a flexible ureterorenoscope.
Key inclusion criteria (4 listed)
- Patient presented with a diagnosis to undergo a ureterorenoscopy using a flexible ureterorenoscope
- over 18 years
- has signed informed consent
- the patient is being treated with the designated flexible ureterorenoscope
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiological load
Time frame: 2 years
To evaluate the pre-operative microbiological load of the tip and the working channel of the most common used flexible ureteroscopes, after high level disinfection
2 secondary outcomes
Durability
Time frame: 2 years
Factors affecting durability
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
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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.
Jean de la Rosette, MD, PhD study chair
Clinical Research Office of the Endourological Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones, run by Clinical Research Office of the Endourological Society at 1 site in Netherlands.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 10 Apr 2018. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microbiological load (time frame: 2 years). 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 10 Apr 2018.