| CTRI Number |
CTRI/2025/08/092500 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Accuracy of Smart Scope Screening device for Cervical Cancer |
|
Scientific Title of Study
|
Assessment of Predictive Accuracy of Indian-Make Artificial intelligence enabled Smart Scope as Point-of-Care Screening and Triaging tool for Cervical Cancer Screening |
| 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 Ritu Sharma |
| Designation |
Professor and Head of Department of Obstetrics and Gynaecology |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Room no. 4152, 4rth floor, Department of Obstetrics and Gynaecology Government Institute of Medical Sciences (GIMS) Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9717001590 |
| Fax |
|
| Email |
drritu661@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Garima Singh |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Obstetrics and Gynaecology Government Institute of Medical Sciences (GIMS) Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9794371207 |
| Fax |
|
| Email |
garima002singh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Singh |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Obstetrics and Gynaecology Government Institute of Medical Sciences (GIMS) Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
9794371207 |
| Fax |
|
| Email |
garima002singh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences(GIMS) Kasna
Greater Noida
pin 201310 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences(GIMS) |
| Address |
Government Institute of Medical Sciences(GIMS) Kasna
Greater Noida
pin 201310 |
| Type of Sponsor |
Government 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 Ritu Sharma |
Government Institute of Medical Sciences (GIMS) |
Department of Obstetrics and Gynaecology Government Institute of Medical Sciences (GIMS) Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9717001590
drritu661@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Sexually active women aged between 25 and 65 years.
2.Women presenting with complaints of white discharge per vagina, vaginal itching, or lower abdominal pain.
3.Women with abnormal per vaginal bleeding.
4.Women found to have a clinically unhealthy cervix on per speculum examination.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women.
2.Women with a history of prior treatment for cervical cancer.
3.Women with a history of hysterectomy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the sensitivity, specificity, NPV, and PPV of Artificial intelligence enabled Smart Scope (AI-SS), Visual Inspection after Acetic acid application VIA/ Visual Inspection after Lugol’s Iodine application VILI, and colposcopy in comparison with histopathology.
2.To compare the sensitivity, specificity, NPV, and PPV of Artificial intelligence enabled Smart Scope (AI-SS) with that of the Visual Inspection after Acetic acid application VIA/ Visual Inspection after Lugol’s Iodine application VILI and colposcopy.
|
From baseline to end of study at day7 week 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the sensitivity, specificity, NPV, and PPV of PAPs in comparison with histopathology.
2.To assess satisfaction of healthcare workers to the Smart Scope procedure.
|
From baseline to end of study at day 7 week 1 |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
20/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
MATERIALS AND METHODS Study Design: Prospective observational study Study Setting: Department of Obstetrics and Gynaecology, Government Institute of Medical Sciences (GIMS), Greater Noida, Uttar Pradesh Study Duration: 12 months Study Population: Women attending the gynaecology outpatient department (OPD) at GIMS. Inclusion Criteria: 1. Sexually active women aged between 25 and 65 years. 2. Women presenting with complaints of white discharge per vagina, vaginal itching, or lower abdominal pain. 3. Women with abnormal per vaginal bleeding. 4. Women found to have a clinically unhealthy cervix on per speculum examination. Exclusion Criteria: 1. Pregnant women. 2. Women with a history of prior treatment for cervical cancer. 3. Women with a history of hysterectomy.
|