FANS VS DISS in Treatment of Renal Stone < 2cm
Flexible and Navigable Access Sheath (FANS) VS Direct in Scope Suction (DISS) in Treatment of Renal Stone > 2 cm , Controlled Randomized Trial
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
To compare between FANS \& DISS in :
- Operative time
- Stone free rate
- Complications
- Amount of fluid irrigation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2026
CompletedFirst Posted
Study publicly available on registry
April 30, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
Study Completion
Last participant's last visit for all outcomes
September 1, 2027
April 30, 2026
April 1, 2026
1 year
April 10, 2026
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Operative time
The operative time is the duration of surgical procedure
<60 minutes
Study Arms (2)
Flexible and navigable access sheath (FANS)
EXPERIMENTALIn patients undergoing the FANS procedure , an access sheath with a bendable tip and aspiration feature will be placed into the relevant ureter up to the renal pelvis over the guidewire. The single-use flexible scope will be passed through the access sheath, and the renal collecting system. After this maneuver, the tip of the placed access sheath will be pushed into the renal calyces or pelvis under the guidance of the flexible URS and a holmium fiber will be used to pulverize the stones with a 273-µm fiber. In this group, stones were disintegrated (fragmented) into an adequate size (\< 3 mm) to allow an efficient extraction with the help of active aspiration, finished by insertion of JJ in all patients.
Direct in scope suction (DISS)
EXPERIMENTALIn the DISS group, a single-use flexible URS with a direct in-scope suction system will be introduced over the placed guidewire and navigated into the renal pelvis without the use of an access sheath. The suctioning port on the ureteroscope and the laser fiber operates via the same port. In this group, the dusting preset of the same laser device will be used to disintegrate the stones. While continuous irrigation was applied to ensure optimum visualization, finished by insertion of JJ in all patients
Interventions
Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation. Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope. While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency
Eligibility Criteria
You may qualify if:
- All patients \< 18 years old presented with renal stone \> 2cm whatever the site of the stone (pelvic or calyceal)
You may not qualify if:
- Inaccessibility to introduce access sheath or FURS
- Previous Inserted JJ stent
- Active UTI
- Patients refuse to participate in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident physician
Study Record Dates
First Submitted
April 10, 2026
First Posted
April 30, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
April 30, 2026
Record last verified: 2026-04