IMproved PRactice Outcomes and Value Excellence in Colposcopy
- Conditions
- High Grade Cervical Intraepithelial Neoplasia
- Interventions
- Device: DySIS
- Registration Number
- NCT02185599
- Lead Sponsor
- DySIS Medical Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 7555
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Colposcopy with DySIS DySIS The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.
- Primary Outcome Measures
Name Time Method Number of subjects diagnosed with CIN2+ cervical lesions At time of colposcopy Changes in number of subjects diagnosed with CIN2+ cervical lesions
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
Unified Women's Clinical Research-Atlanta
🇺🇸Atlanta, Georgia, 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
Dr Gregory Shifrin, OB/GYN, PC
🇺🇸Brooklyn, New York, United States
Lakeside Ob/Gyn-Northeast Georgia Physician Group
🇺🇸Hoschton, Georgia, United States
Brodsky & Taylor, PLC
🇺🇸Ferndale, Michigan, United States
North Florida OB GYN Associates, PA
🇺🇸Jacksonville, Florida, United States
Nye Partners in Women's Health
🇺🇸Chicago, Illinois, United States
Northeast Georgia Physicians Group- Heritage
🇺🇸Gainesville, Georgia, United States
Midwest Center for Women's Healthcare
🇺🇸Elgin, Illinois, United States
Women's Healthcare of Illinois
🇺🇸Mokena, 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 Healthcare of Princeton, LLC
🇺🇸Princeton, New Jersey, United States
Margaret A. Smollen, MD, PC
🇺🇸Iowa City, Iowa, United States
Lyndhurst Clinical Research- Mt Airy
🇺🇸Mount Airy, North Carolina, United States
Hinsdale & Oak Brook Women's Clinic
🇺🇸Willowbrook, Illinois, United States
Laura Bradford, MD
🇺🇸Fort Worth, Texas, United States
Unified Women's Clinical Research-Cary
🇺🇸Cary, North Carolina, United States
Austin Area OB-Gyn
🇺🇸Austin, Texas, United States
Lyndhurst Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Advanced Women's Wellness
🇺🇸Katy, Texas, United States
Coastal Bend Women's center
🇺🇸Corpus Christi, Texas, United States
Dr DeLeon's Women's Healthcare
🇺🇸Rowlett, Texas, United States
Physicians & Surgeons for Women, Inc
🇺🇸Springfield, Ohio, United States
Advanced Ob-Gyn Associates
🇺🇸Richardson, Texas, United States
The University of Toledo
🇺🇸Toledo, Ohio, United States
Las Colinas OBGyn
🇺🇸Irving, Texas, United States
MacArthur OB/GYN
🇺🇸Irving, Texas, United States
New Beginnings, OB/GYN
🇺🇸Springfield, New Jersey, United States
NJ Gynecological Institute
🇺🇸Hackensack, New Jersey, United States
Arizona Oncology
🇺🇸Scottsdale, Arizona, United States
Unified Women's Clinical Research-Gainesville
🇺🇸Gainesville, Florida, United States
Unified Women's Clinical research-Alpharetta
🇺🇸Alpharetta, Georgia, United States
Osceola Ob-Gyn, PA
🇺🇸Kissimmee, Florida, United States
Downriver Obstetrics & Gynecology
🇺🇸Trenton, Michigan, United States
The Women's Center at Southview
🇺🇸Dayton, Ohio, United States
OB-GYN Associates
🇺🇸Cedar Rapids, Iowa, United States
Piedmont Preferred Women's Healthcare Associates
🇺🇸Ridgeway, Virginia, United States
Zeid Women's Health Center
🇺🇸Longview, Texas, United States
Women's Center for Health
🇺🇸Naperville, Illinois, United States
Southwest Women's Healthcare Associates
🇺🇸Olympia Fields, Illinois, United States
Women's Wellness World
🇺🇸Hazel Crest, Illinois, United States
Advocate Illinois Masonic Medical Center - Creticos Cancer Center
🇺🇸Chicago, Illinois, United States
The Advanced Gynecologic Surgery Institute
🇺🇸Naperville, Illinois, United States
Craig Ranch Ob/Gyn
🇺🇸McKinney, Texas, United States