| CTRI Number |
CTRI/2025/11/096839 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
UroSmart helps make urine testing faster, easier, and more accurate for doctors and patients. |
|
Scientific Title of Study
|
Urosmart application for urine sediment analysis and its role in improving accuracy and effeciency in diagnostics |
| 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 Jeyachitra R |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar
Kancheepuram
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar
Kancheepuram
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7904024613 |
| Fax |
|
| Email |
kimiparker4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand |
| Designation |
Professor |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar
Kancheepuram
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar
Kancheepuram
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9944749463 |
| Fax |
|
| Email |
myaminimurali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeyachitra R |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar
Kancheepuram
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar
Kancheepuram
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
7904024613 |
| Fax |
|
| Email |
kimiparker4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jeyachitra R (Self)
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar
Kancheepuram - 602106
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Jeyachitra R |
| Address |
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar Kancheepuram |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Jeyachitra R |
Saveetha Medical College and Hospital |
Department of Pathology,5th floor of the hospital building ,saveetha medical college and hospital,saveetha nagar Kancheepuram
Kancheepuram
TAMIL NADU |
7904024613
kimiparker4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee (SMCH-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N210||Calculus in bladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Mid stream urine obatined patients with lower urinary tract symptoms |
|
| ExclusionCriteria |
| Details |
Contaminated or Turbid samples with visible debris |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine whether the UroSmart application improves the accuracy and efficiency of urine sediment analysis compared to manual microscopy.
|
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include improvements in diagnostic accuracy, efficiency, and usability of the UroSmart urine sediment analysis application compared with standard microscopy. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/12/2025 |
| 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="5"
Days="10" |
|
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
|
UroSmart is an advanced, image-based application that uses artificial intelligence to analyze urine samples quickly and accurately. It identifies and classifies cells, crystals, and other elements in urine sediments, reducing the need for manual microscopic examination. By automating the process, UroSmart minimizes human error, saves time for laboratory staff, and ensures consistent, reliable results. This leads to faster diagnosis of urinary tract infections, kidney disorders, and other related conditions, ultimately improving patient care and clinical efficiency. |