Renal StonesNCT04578795
Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones
A study testing Single use flexible ureteroscopy (PUSEN-OLIMPUS) in people with Renal Stones, run by Menoufia University at 1 site in Egypt.
Trial summary
To study the Effectiveness of single use flexible Ureteroscopes in treatment of renal stones Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Stones
- What is being tested?
- Single use flexible ureteroscopy (PUSEN-OLIMPUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Jul 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All cases indicated for flexible in our department (stone kidney up to 2 cm - failed ESWL, difficult PCNL
Who cannot join
- Staghorn stones
Trial locations and contacts
1 site in 1 country.
About this study
To study the Effectiveness of single use flexible Ureteroscopes in treatment of renal stones
Read the detailed description
The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones .
- Percutaneous nephrolithotomy (PCNL) is currently the gold standard for management of large renal calculi.
- PCNL is associated, however, with a higher complication rate, degree of risk, and longer recovery period compared with ureteroscopy - ESWL was introduced in the 1980s and quickly became the gold standard for the treatment of kidney stones . In the 1990s, URS emerged with the advantages of direct visualization and extraction of kidney calculi .
- Currently, the American Urological Association guideline recommends ESWL or URS as equivalent first-line interventions for the treatment of kidney stones < 20 mm . - The guidelines of the European Association of Urology (EAU) additionally distinguish between lower pole and non-lower pole kidney stones. They recommend both treatments as equivalent options for kidney stones of 1020 mm, but favor URS for lower pole stones if adverse factors (such as anatomy and stone composition) argue against ESWL - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients .
- Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).
- we can distinguish two types of flexible URS: fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - In fiberoptic flexible URS, light and image are transmitted in analog format through fiberoptics bundles whereas illumination in digital scopes is made by fiberoptics or by a diode (DEL) and image capture charged by a digital sensor located at the tip of the endoscope: either charged coupled device (CCD) or complementary metal oxide semiconductor (CMOS ) - In both fiberoptic and digital flexible URS, most manufacturers have models with a 3.6 Fr working channel (for irrigation and use of accessory instruments) and at least one 270° active deflection of the tip. The most recent development in flexible URS was the introduction of single use digital flexible URS .
- On the other hand the traditional reusable scopes have a fixed purchase cost, there is additional cost related to scope processing and repairs . - The cost of single-use flexible URS is defined with the initial purchase price, whereas the procedural cost of reusable flexible URS is dependent on the initial and repair cost, maintenance and scope disinfection and on the number of procedures performed before it needs to be repaired. - There is also the cost of repair and the number of procedures with a refurbished scope until it has to be replaced.
- Conditions
- Renal Stones
- Being tested
- Single use flexible ureteroscopy (PUSEN-OLIMPUS)
- Keywords
- Single use flexible ureteroscopy- renal stones
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single use flexible ureteroscopy (PUSEN-OLIMPUS)Device
single use flexible ureteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Pt underwent single use flexible ureteroscopy | Experimental | Patients with renal stones who will operated by single use flexible ureteroscopy Receives: Device: Single use flexible ureteroscopy (PUSEN-OLIMPUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of renal stones
the effectiveness of single use flexible ureteroscopy in treatment of renal stones in eradicate renal stones
Measured: One month after operation
Secondary outcomes (1)
Post operative complications after flexible ureteroscopy
Post operative complications as fever , haematuria are common after ureteroscopy
Measured: 3 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Kandeel, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578795
- Sponsor's protocol ID
- 9-2020urol
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Single Use Flexible Ureteroscopes in Treatment of Renal Stones
- ClinicalTrials.gov ID
- NCT04578795
- Acronym / sponsor ID
- 9-2020urol
- Conditions
- Renal Stones
- Keywords
- Single use flexible ureteroscopy- renal stones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 8 Oct 2020 (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.
To study the Effectiveness of single use flexible Ureteroscopes in treatment of renal stones
Detailed description
The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones .
- Percutaneous nephrolithotomy (PCNL) is currently the gold standard for management of large renal calculi.
- PCNL is associated, however, with a higher complication rate, degree of risk, and longer recovery period compared with ureteroscopy - ESWL was introduced in the 1980s and quickly became the gold standard for the treatment of kidney stones . In the 1990s, URS emerged with the advantages of direct visualization and extraction of kidney calculi .
- Currently, the American Urological Association guideline recommends ESWL or URS as equivalent first-line interventions for the treatment of kidney stones < 20 mm . - The guidelines of the European Association of Urology (EAU) additionally distinguish between lower pole and non-lower pole kidney stones. They recommend both treatments as equivalent options for kidney stones of 1020 mm, but favor URS for lower pole stones if adverse factors (such as anatomy and stone composition) argue against ESWL - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients .
- Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).
- we can distinguish two types of flexible URS: fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - In fiberoptic flexible URS, light and image are transmitted in analog format through fiberoptics bundles whereas illumination in digital scopes is made by fiberoptics or by a diode (DEL) and image capture charged by a digital sensor located at the tip of the endoscope: either charged coupled device (CCD) or complementary metal oxide semiconductor (CMOS ) - In both fiberoptic and digital flexible URS, most manufacturers have models with a 3.6 Fr working channel (for irrigation and use of accessory instruments) and at least one 270° active deflection of the tip. The most recent development in flexible URS was the introduction of single use digital flexible URS .
- On the other hand the traditional reusable scopes have a fixed purchase cost, there is additional cost related to scope processing and repairs . - The cost of single-use flexible URS is defined with the initial purchase price, whereas the procedural cost of reusable flexible URS is dependent on the initial and repair cost, maintenance and scope disinfection and on the number of procedures performed before it needs to be repaired. - There is also the cost of repair and the number of procedures with a refurbished scope until it has to be replaced.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pt underwent single use flexible ureteroscopy | Experimental | Device: Single use flexible ureteroscopy (PUSEN-OLIMPUS)Patients with renal stones who will operated by single use flexible ureteroscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All cases indicated for flexible in our department (stone kidney up to 2 cm - failed ESWL, difficult PCNL
Key exclusion criteria (1 listed)
- Staghorn stones
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 |
|---|---|---|
| Single use flexible ureteroscopy (PUSEN-OLIMPUS)single use flexible ureteroscopy | Device | Pt underwent single use flexible ureteroscopy |
Primary outcome
Clearance of renal stones
Time frame: One month after operation
the effectiveness of single use flexible ureteroscopy in treatment of renal stones in eradicate renal stones
1 secondary outcome
Post operative complications after flexible ureteroscopy
Time frame: 3 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single use flexible ureteroscopy (PUSEN-OLIMPUS) in people with Renal Stones, run by Menoufia University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Oct 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 Egypt. 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?
Results are not available in the source record.
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?
Clearance of renal stones (time frame: One month after operation). 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 8 Oct 2020.