Health Condition 1: N72- Inflammatory disease of cervix uteri
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria: 1.Pregnant women. 2.Women with a history of prior treatment for cervical cancer. 3.Women with a history of hysterectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: From baseline to end of study at day7 week 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: From baseline to end of study at day 7 week 1 | — |
Countries
India
Contacts
Government Institute of Medical Sciences(GIMS)