Renal StoneNCT06786715
Retrograde Intrarenal Surgery (RIRS) With Suction
A study testing Retrograde intrarenal surgery using DISS and Retrograde intrarenal surgery using FANS in people with Renal Stone, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Suction has been initially used in endoscopic stone management for more than 25 years during PCNL, but the emergence of new devices applying suction through patented ureteroscopes, ureteral access sheaths (UAS) and ureteral catheters led to application of suction in URS/RIRS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stone
- What is being tested?
- Retrograde intrarenal surgery using DISS and Retrograde intrarenal surgery using FANS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Single stone
- Medium sized stone ≤ 3 cm
- Renal stone
- age group > 18
Who cannot join
- multiple renal stones
- stone size > 3 cm
- age group < 18
- solitary kidney
- Obstruction distal to the stone.
- urinary tract infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrograde Intrarenal Surgery (RIRS) With Suction Using Direct in Scope Suction (DISS) Versus Flexible and Navigable Access Sheath (FANS): Randomized Controlled Study
Suction has been initially used in endoscopic stone management for more than 25 years during PCNL, but the emergence of new devices applying suction through patented ureteroscopes, ureteral access sheaths (UAS) and ureteral catheters led to application of suction in URS/RIRS. The application of ureteral access sheath (UAS) in RIRS can improve surgical vision , reduce intrarenal pressure (IRP) ,and decrease postoperative infectious complications .
- Conditions
- Renal Stone
- Being tested
- Retrograde intrarenal surgery using DISS, Retrograde intrarenal surgery using FANS
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde intrarenal surgery using DISSDevice
Retrograde intrarenal surgery using Direct in scope suction for renal stone up to 3 cm
Retrograde intrarenal surgery using FANSDevice
Retrograde intrarenal surgery using Flexible and navigable suction for renal stone up to 3 cm
| Study group | Role | What they receive |
|---|---|---|
| Retrograde intrarenal surgery using DISS | Active comparator | Retrograde intrarenal surgery using DISS Receives: Device: Retrograde intrarenal surgery using DISS |
| Retrograde intrarenal surgery using FANS | Active comparator | Retrograde intrarenal surgery using FANS Receives: Device: Retrograde intrarenal surgery using FANS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
No residual or non siginficant residual less than 4 mm
Measured: One month
Secondary outcomes (2)
Operatove data
Operation and radiation time
Measured: 2 hours
Post operative complication
Fever , sepsis , vomitimg
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StoneStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsayed Abdelhalim Elsayed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786715
- Sponsor's protocol ID
- KFSIRB200-488
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Intrarenal Surgery (RIRS) With Suction Using Direct in Scope Suction (DISS) Versus Flexible and Navigable Access Sheath (FANS): Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06786715
- Acronym / sponsor ID
- KFSIRB200-488
- Conditions
- Renal Stone
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 22 Jan 2025 (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.
Suction has been initially used in endoscopic stone management for more than 25 years during PCNL, but the emergence of new devices applying suction through patented ureteroscopes, ureteral access sheaths (UAS) and ureteral catheters led to application of suction in URS/RIRS. The application of ureteral access sheath (UAS) in RIRS can improve surgical vision , reduce intrarenal pressure (IRP) ,and decrease postoperative infectious complications .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrograde intrarenal surgery using DISS | Active comparator | Device: Retrograde intrarenal surgery using DISSRetrograde intrarenal surgery using DISS |
| Retrograde intrarenal surgery using FANS | Active comparator | Device: Retrograde intrarenal surgery using FANSRetrograde intrarenal surgery using FANS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single stone
- Medium sized stone ≤ 3 cm
- Renal stone
- age group > 18
Key exclusion criteria (6 listed)
- multiple renal stones
- stone size > 3 cm
- age group < 18
- solitary kidney
- Obstruction distal to the stone.
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 |
|---|---|---|
| Retrograde intrarenal surgery using DISSRetrograde intrarenal surgery using Direct in scope suction for renal stone up to 3 cm | Device | Retrograde intrarenal surgery using DISS |
| Retrograde intrarenal surgery using FANSRetrograde intrarenal surgery using Flexible and navigable suction for renal stone up to 3 cm | Device | Retrograde intrarenal surgery using FANS |
Primary outcome
Stone free rate
Time frame: One month
No residual or non siginficant residual less than 4 mm
2 secondary outcomes
Operatove data
Time frame: 2 hours
Post operative complication
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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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 Retrograde intrarenal surgery using DISS and Retrograde intrarenal surgery using FANS in people with Renal Stone, run by Kafrelsheikh 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Stone free rate (time frame: One month). 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 Jan 2025.