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Testing new device for detecting cancer of cervix a part of female genital tract

Diagnostic accuracy of indigenous digital portable colposcope and a conventional colposcope in detection of preinvasive and invasive cervical lesions - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061297
Enrollment
138
Registered
2024-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N72- Inflammatory disease of cervix uteri

Interventions

Intervention1: Indigenous digital portable colposcope: Colposcopy will be performed by Indigenous Digital portable colposcope on study participants consenting to participate in study and fulfilling in

Sponsors

Datta Meghe Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Between 25 and 65 years age 2.Irrespective of marital status, with a history of sexual cohabitation, 3.Complaints of vaginal and blood mixed discharge, foul-smell in discharge, postcoital bleeding, postmenopausal bleeding, Intermenstrual bleeding, lower abdominal pain 4.showing lesion on cervix after visual inspection with acetic acid application and 5.Abnormal Pap smear report: Atypical squamous cells of undetermined significance (ASCUS), atypical squamous cells, cannot exclude HSIL (ASC-H), low-grade intraepithelial lesion (LSIL), high-grade intraepithelial, lesion (HSIL) and cancerous (Ca) on Pap test WAS considered as positive.

Exclusion criteria

Exclusion criteria: 1. Lactating and pregnant women 2 Active vaginal bleeding 3. Frank growth on cervix 4. Post-hysterectomy patients 5. Those who are not sexually active 6. Women who have undergone prior treatment for cervical intraepithelial neoplasia (CIN) and cervical cancer. • Women below 25 years old and above the age of 65 years • Individuals with previous history of any systemic malignancies or any other major systemic terminal disease • Individuals who will refuse to participate or give informed consent

Design outcomes

Primary

MeasureTime frame
primary outcome will measure the level of agreement and ? (kappa) statistic between both devices. The agreement on colposcopy findings between the two methods will be determined using Cohen’s Kappa coefficient.Timepoint: at 4 weeks

Secondary

MeasureTime frame
our secondary outcome measure will be level of agreement between 2 devices in terms of its performanceTimepoint: at baseline

Countries

India

Contacts

Public ContactDr Anupama Bhute

Jawaharlal Nehru Medical College

deepti_shrivastava69@gmail.com09767774179

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026