| CTRI Number |
CTRI/2026/04/108750 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two modalities of endoscopic renal stone surgery. |
|
Scientific Title of Study
|
Prospective randomised controlled trial to evaluate the efficay of a flexible and navigable suction ureteric access sheath on renal stone clearance compared to conventional access sheath in adult patients of renal stone disease undergoing Retrograde Intrarenal Surgery (RIRS). |
| Trial Acronym |
FANS vs Conventional UAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VIPIN CHANDRA |
| Designation |
Associate Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Room No - 341, Urology OPD, AIIMS Patna
Phulwari sharif
phulwari sharif patna
Patna
BIHAR
801505
India |
| Phone |
08442840839 |
| Fax |
|
| Email |
ccchandra2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIPIN CHANDRA |
| Designation |
Associate Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Room No - 341, Urology OPD, AIIMS Patna
Phulwari sharif
phulwari sharif patna
Patna
BIHAR
801505
India |
| Phone |
08442840839 |
| Fax |
|
| Email |
ccchandra2001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIPIN CHANDRA |
| Designation |
Associate Professor |
| Affiliation |
AIIMS PATNA |
| Address |
Room No - 341, Urology OPD, AIIMS Patna
Phulwari sharif
phulwari sharif patna
Patna
BIHAR
801505
India |
| Phone |
08442840839 |
| Fax |
|
| Email |
ccchandra2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Patna, Phulwari sharif, 801507 |
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
Neae WALMI, Phulwari sharif patna |
| Type of Sponsor |
Research institution |
|
|
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 Vipin Chandra |
AIIMS Patna |
Department of Urology
All India Institute of Medical sciences, Patna-801507
Patna
BIHAR |
8442840839
ccchandra2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| aiimspatna |
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 |
Conventional ureteric access sheath in adult patients of renal stone disease undergoing Retrograde Intrarenal Surgery (RIRS) |
Use of conventional UAS, to evaluate their efficacyin adult patients of renal stone disease undergoing Retrograde Intrarenal Surgery (RIRS) for a period of 2 years. |
| Intervention |
Flexible and Navigable suction ureteric access sheath in adult patients of renal stone disease undergoing Retrograde Intrarenal Surgery (RIRS) |
A specially designed flexible and navigable suction ureteric access sheath (FANS-UAS) is being compared with conventional UAS, to evaluate their efficacyin adult patients of renal stone disease undergoing Retrograde Intrarenal Surgery (RIRS) for a study period of 2 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having renal stone planned for retrograde intrarenal surgery |
|
| ExclusionCriteria |
| Details |
Pregnant female
Acute Infection/UTI
Coagulopathy
Anatomical anomaly |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stone-free rate at 1st postoperative day and on day 30 after surgery. |
Postoperative day 1 and
Postoperative day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative fever
operative fever |
1 month |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Renal calculi are a prevalent urological issue worldwide. Retrograde Intrarenal Surgery (RIRS) has become a primary minimally invasive treatment, especially for upper urinary tract stones. While effective, conventional RIRS using a standard ureteric access sheath (UAS) has known limitations. Elevated intrarenal pressure during the procedure is a significant concern, increasing the risk of postoperative fever and sepsis. Furthermore, inefficient removal of stone fragments ("dust") can lead to lower stone-free rates (SFR), potentially requiring secondary procedures. The conventional UAS can be stiff, posing challenges in tortuous ureters and limiting the evacuation of fragments. This study aims to address key safety and efficacy challenges in RIRS. A specially designed flexible and navigable suction ureteric access sheath (FANS-UAS) offers potential solutions by reducing intrarenal pressure, better navigability, and better stone evacuation. |