Cancer of the cervix is a leading cause of death in Indian women and contributes to nearly one fourth of the world burden of cervical cancer incidence and mortality. Access to screening and health services is also a major barrier for success in cervical cancer screening programs. Pap smear test, a multi-visit screening test, is known to have low sensitivity. As per the recommendations of R. Sankarnarayanan for cervical screening in low resource setting, Visual Inspection with Acetic Acid (VIA) followed by Visual Inspection with Lugol’s Iodine (VILI) is a sufficiently sensitive and specific technique when performed by trained and semi-skilled paramedical professionals.

Periwinkle Technologies has developed the digital viewing device “Smart Scope® ”. Smart Scope’ is a portable, electricity independent device which offers ‘single visit test result’ at an affordable cost in a primary healthcare OPD setup. This device further enhances the efficacy of VIA-VILI test by allowing close examination (3 to 4cm) of the cervix, maneuverability, digital log keeping and remote consultation. SO far we have used Smart copy assessment as a screening tool for cervix for more than 1500 women (data yet to be published). Now, with the desire to improve the efficiency of clinical care, we have introduced Artificial Intelligence (AI) based Machine Learning enabled auto-assessment feature in the software platform of Smart Scope® . The auto-assessment feature will classify ecto-cervix into 4 categories viz., normal (green) / abnormal benign changes (amber) / High Risk Amber (HRA)/ pre-cancerous & cancerous changes (red). This will negate the subjectivity from interpretation of lesions and remove the dependency on trained manpower at primary health centers.

Many studies have been undertaken to evaluate AI performance in oncology, its application in clinical use and cancer care. We have developed (trained and validated in lab) one such Machine Learning (ML) Model. . This is an observational, non-randomized single arm trial to be conducted at a single centre in India for validating the artificial intelligence of cervical image captured by Smart Scope against Colposcopy. The study will enroll 150 women and is expected to continue for 12 months. The efficacy of this classification will be verified with colposcopy for all and histopathology as a gold standard, where ever applicable.