IMproved PRactice Outcomes and Value Excellence in Colposcopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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IMproved PRactice Outcomes and Value Excellence in Colposcopy

Conditions
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High Grade Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Device: DySIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females 21 years or older Able to give informed consent Referred for colposcopy with a screening test result that indicates the need for a colposcopy, based on guidelines and practice: HSIL, ASC-H, LSIL cytology 2x ASC-US cytology (25 or above) 2x/3x LSIL/ASC-US cytology (21-24) ASC-US pap and hrHPV cotest/reflex HPV 16/18 primary screening (≥25) ASC-US pap after hrHPV hrHPV x2 (≥30) HPV16 or 16 after negative cytology/hrHPV (≥30) Follow-up of CIN2/3 biopsy (younger women) hrHPV and/or ≥ASC-US pap post-excision Exclusion Criteria: Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer Pregnancy Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS) Referred for vulva/vaginal disease

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colposcopy with DySIS<br>The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS. | Device: DySIS<br>* Colposcopy performed with the DySIS digital colposcope<br>|
| Standard colposcopy<br>The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects diagnosed with CIN2+ cervical lesions | Changes in number of subjects diagnosed with CIN2+ cervical lesions | At time of colposcopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colposcopy, CIN, cervical neoplasia, cervical dysplasia, cervical cancer, CIN2+