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Brief Title: IMproved PRactice Outcomes and Value Excellence in Colposcopy
Official Title: IMproved PRactice Outcomes and Value Excellence in Colposcopy
Study ID: NCT02185599
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.
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Arizona Oncology, Scottsdale, Arizona, United States
Unified Women's Clinical Research-Gainesville, Gainesville, Florida, United States
North Florida OB GYN Associates, PA, Jacksonville, Florida, United States
Osceola Ob-Gyn, PA, Kissimmee, Florida, United States
Unified Women's Clinical research-Alpharetta, Alpharetta, Georgia, United States
Unified Women's Clinical Research-Atlanta, Atlanta, Georgia, United States
Northeast Georgia Physicians Group- Heritage, Gainesville, Georgia, United States
Lakeside Ob/Gyn-Northeast Georgia Physician Group, Hoschton, Georgia, United States
Nye Partners in Women's Health, Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center - Creticos Cancer Center, Chicago, Illinois, United States
Midwest Center for Women's Healthcare, Elgin, Illinois, United States
Advanced Women's Healthcare Specialists, SC, Elk Grove Village, Illinois, United States
Providea Health Partners, LLC, Evergreen Park, Illinois, United States
Women's Wellness World, Hazel Crest, Illinois, United States
Women's Healthcare of Illinois, Mokena, Illinois, United States
The Advanced Gynecologic Surgery Institute, Naperville, Illinois, United States
Women's Center for Health, Naperville, Illinois, United States
Southwest Women's Healthcare Associates, Olympia Fields, Illinois, United States
Hinsdale & Oak Brook Women's Clinic, Willowbrook, Illinois, United States
OB-GYN Associates, Cedar Rapids, Iowa, United States
Margaret A. Smollen, MD, PC, Iowa City, Iowa, United States
Brodsky & Taylor, PLC, Ferndale, Michigan, United States
Downriver Obstetrics & Gynecology, Trenton, Michigan, United States
NJ Gynecological Institute, Hackensack, New Jersey, United States
Women's Healthcare of Princeton, LLC, Princeton, New Jersey, United States
New Beginnings, OB/GYN, Springfield, New Jersey, United States
Dr Gregory Shifrin, OB/GYN, PC, Brooklyn, New York, United States
Unified Women's Clinical Research-Cary, Cary, North Carolina, United States
Unified Women's Clinical Research-Greensboro, Greensboro, North Carolina, United States
Unified Women's Clinical Research- Central Carolina, Greensboro, North Carolina, United States
Lyndhurst Clinical Research- Mt Airy, Mount Airy, North Carolina, United States
Lyndhurst Clinical Research, Winston-Salem, North Carolina, United States
The Women's Center at Southview, Dayton, Ohio, United States
Physicians & Surgeons for Women, Inc, Springfield, Ohio, United States
The University of Toledo, Toledo, Ohio, United States
Austin Area OB-Gyn, Austin, Texas, United States
Coastal Bend Women's center, Corpus Christi, Texas, United States
Laura Bradford, MD, Fort Worth, Texas, United States
Las Colinas OBGyn, Irving, Texas, United States
MacArthur OB/GYN, Irving, Texas, United States
Advanced Women's Wellness, Katy, Texas, United States
Zeid Women's Health Center, Longview, Texas, United States
Craig Ranch Ob/Gyn, McKinney, Texas, United States
Advanced Ob-Gyn Associates, Richardson, Texas, United States
Dr DeLeon's Women's Healthcare, Rowlett, Texas, United States
Piedmont Preferred Women's Healthcare Associates, Ridgeway, Virginia, United States