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Safer Kidney Stone Surgery Using New Flexible Tubes: A Study with Indian Patients

A prospective study on comparision of use of Flexible Suctioning Ureteral Access Sheath versus Traditional Ureteral Access Sheath for Flexible Ureterorenoscope to treat Unilateral Renal Calculi - FANS-IRP Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091760
Enrollment
300
Registered
2025-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: N200- Calculus of kidney Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Flexible and Navigable Ureteral Access Sheath: Flexible and Navigable Ureteral Access Sheath (FANS) in Flexible Ureterorenoscopy for Unilateral Renal Calculi Control Intervention1: Trad

Sponsors

Sri Ramachandra institute of Higher education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged between 18 and 70 years undergoing flexible ureterorenoscopy (FURS) for unilateral renal calculi measuring between 10 and 20 millimeters were eligible. Inclusion criteria included written informed consent for pre-stenting, postoperative stent removal after 30 days, and serial computed tomography (CT) evaluations on postoperative day 1 and day 30.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had a history of prior retrograde intrarenal surgery, active urinary tract infection, known coagulopathy, anatomical abnormalities of the urinary tract, history of urinary diversion, or if they required bilateral stone surgery or ureteral stone surgery.

Design outcomes

Primary

MeasureTime frame
Stone Free Rate, Operative Time, Intra Renal Pressure, Complication Rate.Timepoint: Pre-operative - 2 weeks before surgery, Intraoperative, Postoperative Day 1 and Day 30, Follow-up 3 months.

Secondary

MeasureTime frame
Laser Activation time, Hemoglobin loss, Hospital stay, Relook Flexible URS, Clavien Dindo grading of complications.Timepoint: Pre-operative - 2 weeks before surgery, Intraoperative, Postoperative Day 1 and Day 30, Follow-up 3 months.

Countries

India

Contacts

Public ContactRajan Ravichandran

Sri Ramachandra Institute of Higher medical Education and Research

drrajancmc21@gmail.com9597881285

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026