Flexible UreteroscopyNCT06122129
Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones
A study testing Flexible ureteroscope with ureteral access sheath and Flexible ureteroscope without ureteral access sheath in people with Flexible Ureteroscopy and Ureteral Access Sheath, run by New Valley University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexible Ureteroscopy, Ureteral Access Sheath, Large Renal Stones
- What is being tested?
- Flexible ureteroscope with ureteral access sheath and Flexible ureteroscope without ureteral access sheath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Nov 2023to 20 Mar 2024
- 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
- Age > 18 years old.
- Both sexes.
- Patients with upper ureter and renal stones scheduled for flexible ureteroscope.
Who cannot join
- Patients with associated distal ureteral stone, kidney transplant or any kind of urinary diversion.
- Larger stones (11 cm) where the routine use of an access sheath will be felt appropriate to aid multiple passes of the scope.
- Known ureteric strictures.
- Concomitant ureteric stones.
- Patients with narrow ureter where ureteral access sheath was anticipated to be difficult.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones: a Randomized Controlled Trial.
The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).
Read the detailed description
Treating a large renal stone, more than 2 cm, is changing during the last decades. Technological innovations have led to a significant improvement in flexible ureteroscopes over recent years.
Many authors have used flexible ureteroscope (FURS) with laser fragmentation as proved treating modality with high efficacy. Although percutaneous extraction of large renal stones is still the first option, it has higher and more severer complications than flexible ureteroscopy.
FURS has developed into a standard diagnostic and treatment modality for upper urinary stone disease, transitional cell carcinoma and ureteral strictures. Indeed, more recently FURS is becoming a minimally invasive competitor to percutaneous nephrolithotomy for larger kidney stones as well as an accepted modality for localized treatment of small upper urinary tract transitional cell carcinoma.
The use of ureteral access sheath (UAS) is widely recognized as a technique utilized to keep the intrarenal pressure low when performing FURS for larger and more complex stones, although some authors advocate its use for most renal stones. UASs are now produced with varying characteristics including various lengths, diameters, materials, dilator tip designs, radiopaque markers, and stiffness. However, it also rises surgical costs and may injure the ureteral wall.
Most common reasons cited by urologists for using a UAS are to facilitate repeated entrance into the ureter and collecting system (as a time-saver), lower intrarenal pressure and protection of ureteroscope and ureter when extracting stone fragments. UAS has encouraged urologists in the fragmentation of large stones; it facilitates multiple entries and stone extraction during FURS.
- Being tested
- Flexible ureteroscope with ureteral access sheath, Flexible ureteroscope without ureteral access sheath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible ureteroscope with ureteral access sheathProcedure or surgery
The flexible ureteroscope either directly or via an access sheath, depending on the size of the ureter, a 9.5/11.5 Fr or a 12 Fr access sheath will be used.
Flexible ureteroscope without ureteral access sheathProcedure or surgery
Ureteroscopy will be carried out without a ureteral access sheath
| Study group | Role | What they receive |
|---|---|---|
| Flexible ureteroscope with ureteral access sheath | Experimental | Stones will be treated by flexible ureteroscope with ureteral access sheath Receives: Procedure: Flexible ureteroscope with ureteral access sheath |
| Flexible ureteroscope without ureteral access sheath | Active comparator | Stones will be treated by flexible ureteroscope without ureteral access sheath Receives: Procedure: Flexible ureteroscope without ureteral access sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Time from sterilization till the end of surgery
Measured: Intraperatively
Secondary outcomes (4)
Stone-free rate
Stone-free status was defined as no residual stones or residual stones with a maximum diameter ≤ 4 mm with no clinical symptoms at 1 month after the procedure
Measured: 28 days after intervention
Complications
Complications such as mucosal lacerations, bleeding, urosepsis, and stein Strasse.
Measured: 28 days after intervention
Duration of stay
Time from admission till hospital discharge
Measured: 28 days after intervention
Number of patients who need ancillary procedures
Need for Ancillary Procedures if there was residual.
Measured: 28 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start8 Nov 2023
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexible UreteroscopyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waheed Fawzy Abdelrasol, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122129
- Sponsor's protocol ID
- 0739-20233
- Status last verified
- Mar 2024
- First submitted
- 26 Oct 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Ureteroscopy With and Without Ureteral Access Sheath in Treatment of Large Renal Stones: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06122129
- Acronym / sponsor ID
- 0739-20233
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 8 Nov 2023 (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.
The aim of this study is to evaluate the flexible ureteroscope (FURS) technique with and without ureteral access sheath (UAS).
Detailed description
Treating a large renal stone, more than 2 cm, is changing during the last decades. Technological innovations have led to a significant improvement in flexible ureteroscopes over recent years.
Many authors have used flexible ureteroscope (FURS) with laser fragmentation as proved treating modality with high efficacy. Although percutaneous extraction of large renal stones is still the first option, it has higher and more severer complications than flexible ureteroscopy.
FURS has developed into a standard diagnostic and treatment modality for upper urinary stone disease, transitional cell carcinoma and ureteral strictures. Indeed, more recently FURS is becoming a minimally invasive competitor to percutaneous nephrolithotomy for larger kidney stones as well as an accepted modality for localized treatment of small upper urinary tract transitional cell carcinoma.
The use of ureteral access sheath (UAS) is widely recognized as a technique utilized to keep the intrarenal pressure low when performing FURS for larger and more complex stones, although some authors advocate its use for most renal stones. UASs are now produced with varying characteristics including various lengths, diameters, materials, dilator tip designs, radiopaque markers, and stiffness. However, it also rises surgical costs and may injure the ureteral wall.
Most common reasons cited by urologists for using a UAS are to facilitate repeated entrance into the ureter and collecting system (as a time-saver), lower intrarenal pressure and protection of ureteroscope and ureter when extracting stone fragments. UAS has encouraged urologists in the fragmentation of large stones; it facilitates multiple entries and stone extraction during FURS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible ureteroscope with ureteral access sheath | Experimental | Procedure: Flexible ureteroscope with ureteral access sheathStones will be treated by flexible ureteroscope with ureteral access sheath |
| Flexible ureteroscope without ureteral access sheath | Active comparator | Procedure: Flexible ureteroscope without ureteral access sheathStones will be treated by flexible ureteroscope without ureteral access sheath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years old.
- Both sexes.
- Patients with upper ureter and renal stones scheduled for flexible ureteroscope.
Key exclusion criteria (5 listed)
- Patients with associated distal ureteral stone, kidney transplant or any kind of urinary diversion.
- Larger stones (11 cm) where the routine use of an access sheath will be felt appropriate to aid multiple passes of the scope.
- Known ureteric strictures.
- Concomitant ureteric stones.
- Patients with narrow ureter where ureteral access sheath was anticipated to be difficult.
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 |
|---|---|---|
| Flexible ureteroscope with ureteral access sheathThe flexible ureteroscope either directly or via an access sheath, depending on the size of the ureter, a 9.5/11.5 Fr or a 12 Fr access sheath will be used. | Procedure or surgery | Flexible ureteroscope with ureteral access sheath |
| Flexible ureteroscope without ureteral access sheathUreteroscopy will be carried out without a ureteral access sheath | Procedure or surgery | Flexible ureteroscope without ureteral access sheath |
Primary outcome
Operative time
Time frame: Intraperatively
Time from sterilization till the end of surgery
4 secondary outcomes
Stone-free rate
Time frame: 28 days after intervention
Complications
Time frame: 28 days after intervention
Duration of stay
Time frame: 28 days after intervention
Number of patients who need ancillary procedures
Time frame: 28 days after intervention
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 22 Mar 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
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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 Flexible ureteroscope with ureteral access sheath and Flexible ureteroscope without ureteral access sheath in people with Flexible Ureteroscopy and Ureteral Access Sheath, run by New Valley 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 3 inclusion and 5 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 22 Mar 2024. 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?
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?
Operative time (time frame: Intraperatively). 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 22 Mar 2024.