IMproved PRactice Outcomes and Value Excellence in Colposcopy

Launched by DYSIS MEDICAL INC. · Jul 8, 2014

Keywords

ClinConnect Summary

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 ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Females 21 years or older
• • 2. Able to give informed consent
• 3. 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:
• • 1. Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer
• • 2. Pregnancy
• • 3. Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
• • 4. Referred for vulva/vaginal disease