| CTRI Number |
CTRI/2024/09/074121 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Research utilizing Artificial Intelligence software in Ultrasound machines to improve fetal imaging |
|
Scientific Title of Study
|
Role of Artificial Intelligence in Fetal Imaging Workflows, Prospective evaluation |
| 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 K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 711, Mother and Child Block, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 711, Mother and Child Block, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Aparna Sharma |
| Designation |
Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No. 711, Mother and Child Block, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9711824415 |
| Fax |
|
| Email |
kaparnasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Origin Medical Research Lab, #644, 2/3/4 Floor, 12th Cross Road, 27th main road, Sector-1 HSR Layout,Bengaluru, Karnataka, India, PIN-560102 |
|
|
Primary Sponsor
|
| Name |
Origin Medical Research Lab, India |
| Address |
#644, 2/3/4 Floor, 12th Cross Road, 27th main road, Sector-1 HSR Layout,Bengaluru, Karnataka-560102 |
| Type of Sponsor |
Other [Healthcare and Life Sciences Company] |
|
|
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 K Aparna Sharma |
All India Institute of Medical Sciences |
Department of Obstetrics and Gynaecology & Department of Radiology, All India Institute of Medical Sciences, New Delhi, Ansari Nagar-110029
South
DELHI |
09711824415
kaparnasharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Normal and Singleton pregnancies with no clinical indications of fetal anomaly prior to the exam
2. Gestational age between 11weeks+ 0 days to 13 weeks +6 days by last menstrual date(LMP) or ultrasound report if uncertain LMP |
|
| ExclusionCriteria |
| Details |
1. Multiple pregnancies
2. Non-readable images(i.e., images with excessive shadows) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Evaluate the diagnostic agreement between OMEA(Origin Medical Exam Assistant, a browser-based software as a medical device)- assisted examinations and traditional examinations
2. Assess the precision of fetal/obstetric measurements obtained with OMEA compared to standard practices
3. Determine the feasibility of introducing OMEA in the real-clinical setting |
Gestational age of fetus between 11 to 13 weeks and 6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. In accordance with practice guidelines, Sensitivity and Specificity of the OMEA in :
a) Detecting diagnostic views from obstetric ultrasound examinations
b) Identifyin anatomical structures/landmarks within the diagnostic views from obstetric ultrasound examinations
c) Annonating the anatomical structures/landmarks identified within the diagnostic views
d) Determinig the quality criteria required for clinical evaluation of diagnostic views
2.Reproducibility and repeatability of the OMEA in performing obstetric measurements
3. Workflow efficiency of OMEA for obstetric measurements performed on obstetric ultrasound examinations at relevant anatomical landmarks |
Gestational age of fetus between 11 to 13 weeks and 6 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/10/2024 |
| 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="1"
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 - NO
|
|
Brief Summary
|
Antenatal ultrasonography aids in assessing the growth of the fetus along with the birth abnormalities, enabling the fetus to receive timely and effective treatment before or after the delivery. Origin Medical Exam Assistant(OMEA) is a browser-based software as a medical device(SaMD) intended to aid Healthcare professionals(HCPs) in the analysis and interpretation of fetal/obstetric images and clips using Artificial Intelligence(AI)/Machine learning(ML) algorithms in real-time during fetal/obstetric examinations. In traditional fetal ultrasound imaging, multiple factors affect the accuracy of the ultrasound examination, such as high fetal mobility, excessive maternal abdominal thickness, HCP’s skills and experience, and inter-observer variability. Moreover, the traditional fetal ultrasound significantly impacts the clinical workflow by increasing the workload leading to longer examination times, causing diagnostic delays that negatively impact patient outcomes, necessitating more equipment and highly trained HCPs. Recent advancements in AI/ML are revolutionizing the field of radiology by augmenting the capabilities of HCPs, improving diagnostic accuracy and enhancing patient care outcomes. |