| CTRI Number |
CTRI/2025/07/091748 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial to evaluate the use of flexible suction access sheath (tube) to improve the stone clearance in kidney surgery using minimal access(endoscopic) methods |
|
Scientific Title of Study
|
Prospective Randomized Controlled Trial Comparing Traditional Access Sheath and Novel Tip-Flexible Suctioning Ureteral Access Sheath Combined with Flexible Ureteroscope in the Treatment of Renal Calculi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanchit Mittal |
| Designation |
Senior Resident |
| Affiliation |
Amrita Institute of Medical sciences |
| Address |
Department of Urology, AIMS Kochi,
Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9897226790 |
| Fax |
|
| Email |
sanchit.mitttal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Georgie Mathew |
| Designation |
consultant |
| Affiliation |
Amrita Institute of Medical sciences |
| Address |
Room number 5,Department of Urology G Block,8 floor, AIMS Kochi
Kerala, India pincode 682041
Ernakulam
KERALA
682041
India |
| Phone |
9897226790 |
| Fax |
|
| Email |
georgiemathewuro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanchit Mittal |
| Designation |
Senior Resident |
| Affiliation |
Amrita Institute of Medical sciences |
| Address |
Department of Urology, AIMS Kochi,
Kerala
KERALA
682041
India |
| Phone |
9897226790 |
| Fax |
|
| Email |
sanchit.mitttal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical sciences
Kochi , Kerala, India, pincode 682041
contact number 0484-4001320 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical sciences Kochi |
| Address |
Department of Urology, AIMS Kochi,
Kerala-Primary centre
India, Pincode 682041
contact number 0484-4001320
|
| 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 sanchit mittal |
Amrita institute of Medical sciences Kochi |
Reserch Room ,Department of Urology , 8 floor G Block Kochi
Kerala , India, Pincode 682041.
contact number 9897226790
Ernakulam
KERALA |
9897226790
sanchit.mitttal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Amrita school of Medicine |
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 access sheath used for performing RIRS |
routine access sheath used for performing RIRS will be used in control patients during the complete duration of surgery.
total of 60 patients will be taken for control to statistical significance |
| Intervention |
use of Novel Tip flexible suctioning access sheath |
instead of traditional access sheath sheath that is used world over for performing RIRS we will be using the flexible suctioning access sheath for performing RIRS for the duration of complete procedure in target group of patients
60 patients in each group will be taken to make the study statistically significant |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical diagnosis of renal calculi
Patients fit to undergo RIRS surgery
|
|
| ExclusionCriteria |
| Details |
Patient who are not cleared for anesthesia
Individuals who are unable to give valid informed consent would be excluded from the study
In patient in whom access sheath could not be placed will be excluded from study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stone-Free Rate
Stone Clearance Rate |
POD1
one and three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
duration of surgery
incidence of infection
need for secondary procedures
rate of intraoperative and post operative complications |
intraoperative period
30 days post-surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sanchit.mitttal@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This randomized controlled study aims to evaluate the efficacy and
safety of the flexible and navigable suction ureteral access sheath (NTFS-UAS)
compared to the traditional access sheath (T-UAS) in patients undergoing
retrograde intrarenal surgery (RIRS). Patients presenting to the Urology OPD
and scheduled for RIRS will be randomized into two groups using software. One
group will use the traditional access sheath, while the other will use the
NTFS-UAS. Study Parameters
Stone Clearance Rate
Duration of Surgery
Stone-Free Rate: Assessed at Day 1, 1 month, and 3 months
postoperatively.
Need for Ancillary Procedures
Complication Rates: Including infection rates.
Imaging and Measurement
Radiopaque Calculi: Patients with stones having a Hounsfield Unit (HU)
of more than 1000 will have their residual stone bulk and clearance rates
compared using X-ray imaging.
Radiolucent Calculi: Patients with stones having a HU of less than 1000
will undergo CT scans to compare stone bulk in the preoperative and
postoperative periods.
This study will provide comprehensive data to determine which access
sheath is superior in terms of surgical duration, stone clearance, ancillary
procedure requirements, and infection rates. |