| CTRI Number |
CTRI/2025/10/096605 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study Comparing Flexible vs. Traditional Access Tubes for Minimally Invasive Kidney Stone Surgery |
|
Scientific Title of Study
|
Comparison of Flexible and Navigable Suction Ureteral Access Sheath (FANS)
and Traditional Ureteral Access Sheath in Retrograde lntrarenal Surgery for
Renal Calculi - A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balaji Subramaniam |
| Designation |
Senior Resident |
| Affiliation |
SRM Medical College Hospital & Research Centre |
| Address |
Department of Urology, 5th floor, SRM Medical College Hospital & Research Centre, SRM Nagar, Kattankulathur, Tamil Nadu
Chennai
TAMIL NADU
603211
India |
| Phone |
9841468834 |
| Fax |
|
| Email |
drbalaji145@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Senthil Kumar T |
| Designation |
Professor & HOD |
| Affiliation |
SRM Medical College Hospital & Research Centre |
| Address |
Department of Urology, 5th floor, SRM Medical College Hospital & Research Centre, SRM Nagar, Kattankulathur, Tamil Nadu
Chennai
TAMIL NADU
603211
India |
| Phone |
9841468834 |
| Fax |
|
| Email |
hod.urolog.ktr.med@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Senthil Kumar T |
| Designation |
Professor & HOD |
| Affiliation |
SRM Medical College Hospital & Research Centre |
| Address |
Department of Urology, 5th floor, SRM Medical College Hospital & Research Centre, SRM Nagar, Kattankulathur, Tamil Nadu
Chennai
TAMIL NADU
603211
India |
| Phone |
9841468834 |
| Fax |
|
| Email |
hod.urolog.ktr.med@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| NIL |
| SRM Medical College Hospital Research Centre, SRM Nagar, Kattankulathur, Chennai
TAMIL NADU
603211
India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Balaji Subramaniam |
SRM Medical College Hospital & Research Centre |
Department of Urology, SRM Medical College Hospital & Research Centre
Chennai
TAMIL NADU |
9841468834
drbalaji145@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL & RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Traditional Ureteral Access Sheath |
Standard operative timing for each RIRS procedure is around 1 hour. Traditional method of performing Retrograde lntrarenal Surgery for renal calculi. |
| Intervention |
Using Flexible and Navigable Suction Ureteral Access Sheath (FANS) while performing RIRS surgery. |
Standard operative timing for each RIRS procedure is around 1 hour. No extra costs or harm caused to the patient. It is a proven equipment for treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years
No abnormal renal anatomy
Renal or upper ureteric calculi less than 2 cm
Primary RIRS and secondary RIRS where the patients were pre-stented
|
|
| ExclusionCriteria |
| Details |
Children less than 18 years
Renal or upper ureteric calculi more than 2 cm
Abnormal renal anatomy (such as ileal conduit or horseshoe kidney)
Diagnostic ureteroscopy showing narrow ureter
Not willing for the study
Patients with absolute contraindications
Uncontrolled urinary tract infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the immediate stone free rate (SFR) in flexible and navigable suction ureteral access sheath vs traditional ureteral access sheath. To assess the Stone free rate at 1 month after the primary procedure |
To assess the immediate stone free rate (SFR) in flexible and navigable suction ureteral access sheath vs traditional ureteral access sheath. To assess the Stone free rate at 1 month after the primary procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the intra operative & immediate post operative factors associated with both the procedures. |
Intra operative, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "161"
Final Enrollment numbers achieved (India)="161" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
30/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients with renal or ureteric calculus are being treated at our hospital for the same. These patients will undergo their standard treatment protocol only. |