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临床试验/CTRI/2025/07/091131
CTRI/2025/07/091131尚未招募2/3 期

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 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
98
试验地点
1
主要终点
The efficacy and accuracy of Smartphone versus Colposcope in Cervical cancer screening

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 18 months

次要结局

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

研究者

发起方
Department of Obstetrics and Gynecology
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR TEJASWINI H K

Karnataka Institute of Medical Sciences

研究点 (1)

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