| CTRI Number |
CTRI/2025/07/091760 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Safer Kidney Stone Surgery Using New Flexible Tubes: A Study with Indian Patients |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
FANS-IRP Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajan Ravichandran |
| Designation |
Senior Resident |
| Affiliation |
Sri Ramachandra Institute of Higher medical Education and Research |
| Address |
E2 Urology room no 4, 1, Ramachandra Nagar, Porur, Chennai
E2 Urology room no 4, 1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9597881285 |
| Fax |
|
| Email |
drrajancmc21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajan Ravichandran |
| Designation |
Senior Resident |
| Affiliation |
Sri Ramachandra Institute of Higher medical Education and Research |
| Address |
E2 Urology room no 4, 1, Ramachandra Nagar, Porur, Chennai
E2 Urology room no 4, 1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9597881285 |
| Fax |
|
| Email |
drrajancmc21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajan Ravichandran |
| Designation |
Senior Resident |
| Affiliation |
Sri Ramachandra Institute of Higher medical Education and Research |
| Address |
E2 Urology room no 4, 1, Ramachandra Nagar, Porur, Chennai
E2 Urology room no 4, 1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9597881285 |
| Fax |
|
| Email |
drrajancmc21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of Higher education and Research |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra institute of Higher education and Research |
| Address |
1, Ramachandra nagar, Porur, Chennai, 600116 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajan Ravichandran |
Sri Ramachandra Institute of Higher medical Education and Research Hospital |
E2 Urology room no 4, 1, Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU |
9597881285
drrajancmc21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Ramachandra University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Flexible and Navigable Ureteral Access Sheath |
Flexible and Navigable Ureteral Access Sheath (FANS) in Flexible Ureterorenoscopy for Unilateral Renal Calculi |
| Comparator Agent |
Traditional Ureteral Access Sheath |
Traditional Ureteral Access Sheath (T-UAS) in Flexible Ureterorenoscopy for Unilateral Renal Calculi |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stone Free Rate, Operative Time, Intra Renal Pressure, Complication Rate. |
Pre-operative - 2 weeks before surgery, Intraoperative, Postoperative Day 1 and Day 30, Follow-up 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Laser Activation time, Hemoglobin loss, Hospital stay, Relook Flexible URS, Clavien Dindo grading of complications. |
Pre-operative - 2 weeks before surgery, Intraoperative, Postoperative Day 1 and Day 30, Follow-up 3 months. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This single-center, prospective, block-randomized controlled trial evaluated the efficacy and safety of the Flexible and Navigable Ureteral Access Sheath (FANS) compared to the Traditional Ureteral Access Sheath (T-UAS) in patients undergoing flexible ureterorenoscopy (F-URS) for unilateral renal calculi (10–20 mm). A total of 301 patients were block randomized (block size 4) to either the FANS group or the T-UAS group. All patients underwent pre-stenting, real-time intrarenal pressure (IRP) monitoring via a pressure guidewire, and postoperative follow-up with CT scans on Day 1 and Day 30 to assess stone-free rates (SFR). Additional follow-up at 3 months was conducted to evaluate stone recurrence, ureteral strictures, and device-related complications. The primary outcomes assessed were operative time, intraoperative IRP, stone-free rates, and complication rates (Clavien-Dindo classification). Secondary outcomes included laser activation time, hemoglobin loss, hospital stay, and need for relook F-URS.
|