| CTRI Number |
CTRI/2024/01/062036 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of flexible & navigable access sheath with traditional ureteral access sheath during Retrograde Intrarenal Surgery |
|
Scientific Title of Study
|
Comparison of the safety, efficacy and stone-free rate of the new flexible and navigable ureteral access sheath with the traditional ureteral access sheath during Retrograde Intrarenal Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Dinkar Mahajan |
| Designation |
Consultant |
| Affiliation |
Sai Urology Hospital |
| Address |
Sai Urology Hospital,Dept of urology,Vishal Nagar,Gajanan Mandir
Road,Opp CADA office, Aurangabad-431005
Aurangabad
MAHARASHTRA
431005
India
Plot no. 1, Vishal Nagar, Gajanan Mandir Road, Opp. CADA office
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9822321224 |
| Fax |
|
| Email |
drabhaymahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Dinkar Mahajan |
| Designation |
Consultant |
| Affiliation |
Sai Urology Hospital |
| Address |
Sai Urology Hospital,Dept of urology,Vishal Nagar,Gajanan Mandir
Road,Opp CADA office, Aurangabad-431005
Aurangabad
MAHARASHTRA
431005
India
Plot no. 1, Vishal Nagar, Gajanan Mandir Road, Opp. CADA office
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9822321224 |
| Fax |
|
| Email |
drabhaymahajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rekha Uttam Chavan |
| Designation |
Clinical Research Coordinator |
| Affiliation |
Sai urology Hospital |
| Address |
Sai Urology Hospital,Dept of urology,Vishal Nagar,Gajanan Mandir
Road,Opp CADA office, Aurangabad-431005
Aurangabad
MAHARASHTRA
431005
India
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
8380848962 |
| Fax |
|
| Email |
saiurologyhospital23@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAI UROLOGY HOSPITAL
Plot no.: 1, Vishal Nagar, Gajanan Mandir Road, Opp. CADA office |
|
|
Primary Sponsor
|
| Name |
Sai Urology Hospital |
| Address |
Sai Urology Hospital, 1, Vishal Nagar, Gajanan Mandir Road,
Opp.CADA office, Aurangabad. 431005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Abhay Mahajan |
Sai Urology Hospital |
Department of Urology, 1st floor, plot no.1, Vishal Nagar, Gajanan Mandir Road,
Opp. CADA office
Aurangabad
MAHARASHTRA |
9822321224
drabhaymahajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAI UROLOGY HOSPITAL ETHICS COMMITTEE |
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 |
Retrograde intrarenal surgery (RIRS) |
RIRS surgery with the use of traditional ureteral access sheath. |
| Comparator Agent |
Retrograde intrarenal surgery for kidney stones |
RIRS with the use of flexible and navigable ureteral access sheath during the surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patient with renal pelvic and calyceal stones ranging from 10-25 mms undergoing primary or staged RIRS |
|
| ExclusionCriteria |
| Details |
Renal stones more than 25 mms
patient unwilling for Retrograde Intrarenal Surgery
Urosepsis
Bleeding tendencies
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the outcome in terms of stone free rates with the use of flexible and navigable suction (FANS) sheath as compared to the traditional ureteral access sheath (UAS) during retrograde intrarenal surgery (RIRS) |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and efficacy of FANS with the traditional UAS during RIRS |
3 month |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Flexible and navigable ureteral access sheath (FANS) is the latest development for retrograde intrarenal surgery. With the use of this sheath stone fragments can be sucked out of the kidney. This technology probably can improve the stone-free rate. The study aims to find out the incidence of stone-free rate using this newer sheath with the traditional ureteral access sheath. The study will also look at the safety and efficacy of the FANS sheath. |