Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.

The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope.

Colposcopy performed with the DySIS digital colposcope

DySIS

The study will observe and quantify shifts in colposcopy practice and outcome improvements in U.S. community-based cervical screening colposcopy examinations after the introduction of the DySIS colposcope with Advanced Cervical Scan.

The study will collect colposcopy data across multiple sites in two arms; a prospective arm, with DySIS being used for the examination and a retrospective arm, with data retrieved from patient charts.

Each site will contribute data to both arms; the study will collect data on demographics, disease yield, number of biopsies and treatment decisions. Study subjects will receive standard of care procedures and management.

Prospective data will be collected at colposcopy examinations performed using the DySIS digital colposcope on consecutive patients that have been referred for colposcopy after a positive screening test. Retrospective data on colposcopy examinations performed using a standard colposcope will be collected from patient medical records, to capture standard practice to-date as a control for comparisons. The retrospective data will be collected from consecutive examinations performed by the providers participating in the prospective arm and for the preceding year.

IMproved PRactice Outcomes and Value Excellence in Colposcopy

Changes in number of subjects diagnosed with CIN2+ cervical lesions

Spots Global Cancer Trial Database for high grade cervical intraepithelial neoplasia