Skip to main content
Clinical Trials/CTRI/2025/07/091131
CTRI/2025/07/091131
Not yet recruiting
Phase 2/3

To estimate the efficacy of smartphone versus colposcope in cervical cancer screening as a low cost device in low resource setting

Department of Obstetrics and Gynecology1 site in 1 country98 target enrollmentStarted: August 15, 2025Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Department of Obstetrics and Gynecology
Enrollment
98
Locations
1
Primary Endpoint
The efficacy and accuracy of Smartphone versus Colposcope in Cervical cancer screening

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
25.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • All sexually active non pregnant females between the age of 25 to 60 years of age.

Exclusion Criteria

  • 1.Males are excluded 2.All pregnant females 3.Women who have undergone hysterectomy.

Outcomes

Primary Outcomes

The efficacy and accuracy of Smartphone versus Colposcope in Cervical cancer screening

Time Frame: 18 months

Secondary Outcomes

  • To introduce a low cost device for cervical cancer screening in low resource setting(18 months)

Investigators

Sponsor
Department of Obstetrics and Gynecology
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

DR TEJASWINI H K

Karnataka Institute of Medical Sciences

Study Sites (1)

Loading locations...

Similar Trials