SEFUS-LP Trial: Suction-Enhanced Flexible Ureteroscopy for Lower Pole Stones

Comparison of Flexible and Navigable Access Sheath (FANS) Versus Direct In-Scope Suction (DISS) in Flexible Ureteroscopy for Lower Pole Renal Stones: A Prospective Randomized Controlled Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202604751247540

Enrollment

328

Registered

2026-04-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological and Genital Diseases

Interventions

Flexible and Navigable suction sheath Assisted Flexible Ureteroscopy

Sheathless Flexible Ureteroscopy with Direct In Scope Suction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age = 18 years • Solitary or multiple lower pole renal stones measuring 2–3 cm (maximum diameter on NCCT) • Normal contralateral kidney

Exclusion criteria

Exclusion criteria: • Active urinary tract infection • Bleeding disorders or ongoing anticoagulation therapy • Anatomical abnormalities of the kidney or ureter (e.g., UPJ obstruction) • Previous ureteral stenting • Pregnancy

Design outcomes

Primary

Measure	Time frame
Single session complete stone free rate	—

Secondary

Measure	Time frame
1. Complete Stone-Free Rate (CSFR): Absence of any detectable residual fragments on NCCT. 2. Operative Time: Measured as skin-to-skin operative duration in minutes. 3. Fragment Evacuation Efficiency: Need for basket extraction or auxiliary procedures. 4. Perioperative Complications: All intraoperative and postoperative complications occurring within 30 days, graded according to the Clavien–Dindo classification. 5. Postoperative Outcomes: • Fever • Hematuria • Pain requiring intervention • Sepsis 6. Length of Hospital Stay: Measured in days from procedure to discharge. 7. Need for Auxiliary Procedures: Including repeat ureteroscopy or conversion to PCNL.	—

Measure

Time frame

1. Complete Stone-Free Rate (CSFR): Absence of any detectable residual fragments on NCCT. 2. Operative Time: Measured as skin-to-skin operative duration in minutes. 3. Fragment Evacuation Efficiency: Need for basket extraction or auxiliary procedures. 4. Perioperative Complications: All intraoperative and postoperative complications occurring within 30 days, graded according to the Clavien–Dindo classification. 5. Postoperative Outcomes: • Fever • Hematuria • Pain requiring intervention • Sepsis 6. Length of Hospital Stay: Measured in days from procedure to discharge. 7. Need for Auxiliary Procedures: Including repeat ureteroscopy or conversion to PCNL.

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Countries

Egypt

Contacts

Public ContactMohammed Lotfi Amer

Lecturer and consultant of Urology

drmlamer@med.tanta.edu.eg00201001862621

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026