| CTRI Number |
CTRI/2025/07/091131 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To estimate the efficacy of smartphone versus colposcope in cervical cancer screening as a low cost device in low resource setting |
|
Scientific Title of Study
|
To estimate the efficacy of smartphone versus colposcope in cervical cancer screening as a low cost device in low resource setting |
| 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 TEJASWINI H K |
| Designation |
Post graduate |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Department of obstetrics and gynecology ,Karnataka Institute of Medical Sciences
Dharwad
KARNATAKA
580022
India |
| Phone |
9113653324 |
| Fax |
|
| Email |
drtejaswinihk29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogindrakumar M Kabadi |
| Designation |
Associate Professor |
| Affiliation |
Karnataka Institue of Medical Sciences, Hubli |
| Address |
Department of Obstetrics and Gynecology, Karnataka Institute of Medical Sciences
Dharwad
KARNATAKA
580022
India |
| Phone |
9113653324 |
| Fax |
|
| Email |
omkabadi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR TEJASWINI H K |
| Designation |
Post graduate |
| Affiliation |
Karnataka Institute of Medical Sciences, Hubli |
| Address |
Department of Obstetrics and Gynecology, Karnataka Institute of Medical Sciences
Dharwad
KARNATAKA
580022
India |
| Phone |
9113653324 |
| Fax |
|
| Email |
drtejaswinihk29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics and Gynecology |
| Address |
Karnataka Institute of Medical Sciences, Vidyanagar, Hubballi, District- Dharwad, State-Karnataka, India 580021 |
| 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 Tejasswini H K |
Karnataka Institute of Medical Sciences |
Room No. 6, Department of Obstetrics and Gynecology, Karnataka Institute of Medical Sciences, Hubli, 580021
Dharwad
KARNATAKA |
9113653324
drtejaswinihk29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubballi Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CERVICAL CANCER SCREENING |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Screening |
Intervention using a smartphone in cervical cancer screening for a duration of 10-15 min per case |
| Comparator Agent |
Screening |
Smartphone is used as a comparator tool with traditional Colposcope |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All sexually active non pregnant females between the age of 25 to 60 years of age |
|
| ExclusionCriteria |
| Details |
1.Males are excluded
2.All pregnant females
3.Women who have undergone hysterectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy and accuracy of Smartphone versus Colposcope in Cervical cancer screening |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To introduce a low cost device for cervical cancer screening in low resource setting |
18 months |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="6"
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
|
IN THS PRESENT STUDY , WE ASSESS THE EFFICACY OF A SMARTPHONE IN CERVICAL CANCER SCREENING. THIS SIMPLE USE OF SMARTPHONE AS A COLPOSCOPE REPLACEMENT MAY IMPROVE CERVICAL CANCER SCREENING IN POOR RESOURCE COUNTRIES.
AIM OF THE STUDY- TO ASSESS THE EFFICACY OF SMARTPHONE BASED IMAGING FOR CERVICAL CANCER SCREENING COMAPRED TO TRADITIONAL COLPOSCOPY IN LOW RESOURCE SETTINGS.
OBJECTIVES- 1. TO EVALUATE THE DIAGNOSTIC ACCURACY OF SMARTPHONE BASED IMAGING IN DETECTING CERVICAL LESIONS 2. TO ANALYSE COST EFFECTIVENESS OF USING SMARPHONE AS A LOW COST DEVICE IN CANCER SCREENING IN LOW RESOURCE SETTING 3. TO DETERMINE THE FEASIBILITY AND ACCEPTABILITY OF SMARTPHONE 4. TO INVESTIGATE THE POTENTIAL BARRIERS AND FACILITATORS TO IMPLEMENTATION OF SMARTPHONE BASED CERVICAL CANCER SCREENING IN THESE SETTINGS.
MATERIALS- A smartphone with an average cost of 25-30k with a zoom is used in this study.
• A green filter, white LED light source , a handle to fix the smartphone are used
additional to smartphone.
Methodology:
• After obtaining an informed consent, a speculum is inserted into the vaginal
canal and opened to allow for visual inspection of the cervix.
• The cervix is initially grossly inspected with the naked eye and an unfiltered
image is captured. An additional set of images using green filter are obtained.
• An elongated swab containing 5% acetic acid is brushed against the cervix, to dry
up the mucus and cause the Acetowhitening and then still images are captured
with smartphone and colposcope at the same magnification setting.
• Additional images are again captured after aiding with Lugol’s iodine.
• The order of the images acquired by smartphone and colposcope will be
randomized between patients.
• Images acquired with both smartphone and colposcope will be assessed for quality
check by an expert in colposcopy who is blinded with the source of image.
EXPECTED OUTCOME
:
• Feasibility of using low-cost technology for cervical cancer screening in the form of
a mobile smartphone camera to capture images • It can be used in areas having erratic access to electricity hence low power
requirement, easy mobility, low maintenance • In addition, the cost per test is low
• This simple technology may improve cervical cancer screening in poor resource
countries.
|