IMproved PRactice Outcomes and Value Excellence in Colposcopy
NCT ID: NCT02185599
Last Updated: 2020-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7555 participants
OBSERVATIONAL
2014-09-30
2017-10-09
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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Colposcopy with DySIS
The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.
DySIS
Colposcopy performed with the DySIS digital colposcope
Standard colposcopy
The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope.
No interventions assigned to this group
Interventions
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DySIS
Colposcopy performed with the DySIS digital colposcope
Eligibility Criteria
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Inclusion Criteria
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
2. Pregnancy
3. Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
4. Referred for vulva/vaginal disease
21 Years
FEMALE
No
Sponsors
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DySIS Medical Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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IMPROVE-100
Identifier Type: -
Identifier Source: org_study_id
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