IMproved PRactice Outcomes and Value Excellence in Colposcopy (IMPROVE-COLPO)

March 12, 2020 updated by: DySIS Medical Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

7555

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Arizona Oncology
    • Florida
      • Gainesville, Florida, United States, 32605
        • Unified Women's Clinical Research-Gainesville
      • Jacksonville, Florida, United States, 32216
        • North Florida OB GYN Associates, PA
      • Kissimmee, Florida, United States, 34741
        • Osceola Ob-Gyn, PA
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Unified Women's Clinical research-Alpharetta
      • Atlanta, Georgia, United States, 30342
        • Unified Women's Clinical Research-Atlanta
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Physicians Group- Heritage
      • Hoschton, Georgia, United States, 30548
        • Lakeside Ob/Gyn-Northeast Georgia Physician Group
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Nye Partners in Women's Health
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center - Creticos Cancer Center
      • Elgin, Illinois, United States, 60123
        • Midwest Center for Women's Healthcare
      • Elk Grove Village, Illinois, United States, 60007
        • Advanced Women's Healthcare Specialists, SC
      • Evergreen Park, Illinois, United States, 60805
        • Providea Health Partners, LLC
      • Hazel Crest, Illinois, United States, 60429
        • Women's Wellness World
      • Mokena, Illinois, United States, 60448
        • Women's Healthcare of Illinois
      • Naperville, Illinois, United States, 60540
        • The Advanced Gynecologic Surgery Institute
      • Naperville, Illinois, United States, 60540
        • Women's Center for Health
      • Olympia Fields, Illinois, United States, 60461
        • Southwest Women's Healthcare Associates
      • Willowbrook, Illinois, United States, 60527
        • Hinsdale & Oak Brook Women's Clinic
    • Iowa
      • Cedar Rapids, Iowa, United States, 52402
        • OB-GYN Associates
      • Iowa City, Iowa, United States, 52245
        • Margaret A. Smollen, MD, PC
    • Michigan
      • Ferndale, Michigan, United States, 48220
        • Brodsky & Taylor, PLC
      • Trenton, Michigan, United States, 48183
        • Downriver Obstetrics & Gynecology
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • NJ Gynecological Institute
      • Princeton, New Jersey, United States, 08540
        • Women's Healthcare of Princeton, LLC
      • Springfield, New Jersey, United States, 07081
        • New Beginnings, OB/GYN
    • New York
      • Brooklyn, New York, United States, 11229
        • Dr Gregory Shifrin, OB/GYN, PC
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Unified Women's Clinical Research-Cary
      • Greensboro, North Carolina, United States, 27401
        • Unified Women's Clinical Research-Greensboro
      • Greensboro, North Carolina, United States, 27408
        • Unified Women's Clinical Research- Central Carolina
      • Mount Airy, North Carolina, United States, 27030
        • Lyndhurst Clinical Research- Mt Airy
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
    • Ohio
      • Dayton, Ohio, United States, 45459
        • The Women's Center at Southview
      • Springfield, Ohio, United States, 45505
        • Physicians & Surgeons for Women, Inc
      • Toledo, Ohio, United States, 43614
        • The University of Toledo
    • Texas
      • Austin, Texas, United States, 78758
        • Austin Area OB-Gyn
      • Corpus Christi, Texas, United States, 78412
        • Coastal Bend Women's center
      • Fort Worth, Texas, United States, 76104
        • Laura Bradford, MD
      • Irving, Texas, United States, 75062
        • MacArthur OB/GYN
      • Irving, Texas, United States, 75062
        • Las Colinas ObGyn
      • Katy, Texas, United States, 77450
        • Advanced Women's Wellness
      • Longview, Texas, United States, 75601
        • Zeid Women's Health Center
      • McKinney, Texas, United States, 75070
        • Craig Ranch Ob/Gyn
      • Richardson, Texas, United States, 75082
        • Advanced Ob-Gyn Associates
      • Rowlett, Texas, United States, 75088
        • Dr DeLeon's Women's Healthcare
    • Virginia
      • Ridgeway, Virginia, United States, 24148
        • Piedmont Preferred Women's Healthcare Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women referred for colposcopy after an abnormal screening test for prevention of cervical cancer

Description

Inclusion Criteria:

  1. Females 21 years or older
  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:

  1. Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer
  2. Pregnancy
  3. Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
  4. Referred for vulva/vaginal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colposcopy with DySIS
The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects diagnosed with CIN2+ cervical lesions
Time Frame: At time of colposcopy
Changes in number of subjects diagnosed with CIN2+ cervical lesions
At time of colposcopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DySIS Medical Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

October 9, 2017

Study Completion (Actual)

October 9, 2017

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMPROVE-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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