NCT02185599

IMproved PRactice Outcomes and Value Excellence in Colposcopy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,555 (actual)
• Sponsor: DySIS Medical Inc. · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• High Grade Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DEVICE	DySIS	Colposcopy performed with the DySIS digital colposcope

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-10-09
• Completion: 2017-10-09
• First posted: 2014-07-09
• Last updated: 2020-03-13

Locations

46 sites across 1 country: United States