IMproved PRactice Outcomes and Value Excellence in Colposcopy
Completed
Conditions studied: High Grade Cervical Intraepithelial Neoplasia
In brief
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.
Key facts
- Study ID
- NCT02185599
- Run by
- DySIS Medical Inc.
- People needed
- 7555
- Starts
- 2014-09-01
- Expected to finish
- 2017-10-09
- Last updated by the study team
- 2020-03-13
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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