IMproved PRactice Outcomes and Value Excellence in Colposcopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 7,555
- Locations
- 46
- Primary Endpoint
- Number of subjects diagnosed with CIN2+ cervical lesions
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
- •Referred for vulva/vaginal disease
Outcomes
Primary Outcomes
Number of subjects diagnosed with CIN2+ cervical lesions
Time Frame: At time of colposcopy
Changes in number of subjects diagnosed with CIN2+ cervical lesions
Secondary Outcomes
No secondary outcomes reported