Status:
COMPLETED
IMproved PRactice Outcomes and Value Excellence in Colposcopy
Lead Sponsor:
DySIS Medical Inc.
Conditions:
High Grade Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
21+ years
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 colpos...
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 proced...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 9 2017
Estimated Enrollment :
7555 Patients enrolled
Trial Details
Trial ID
NCT02185599
Start Date
September 1 2014
End Date
October 9 2017
Last Update
March 13 2020
Active Locations (46)
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1
Arizona Oncology
Scottsdale, Arizona, United States, 85258
2
Unified Women's Clinical Research-Gainesville
Gainesville, Florida, United States, 32605
3
North Florida OB GYN Associates, PA
Jacksonville, Florida, United States, 32216
4
Osceola Ob-Gyn, PA
Kissimmee, Florida, United States, 34741