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

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ClinicalTrials.gov Identifier: NCT02185599
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
High Grade Cervical Intraepithelial Neoplasia Device: DySIS

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
Actual Enrollment : 7529 participants
Observational Model: Other
Time Perspective: Other
Official Title: IMproved PRactice Outcomes and Value Excellence in Colposcopy
Actual Study Start Date : September 2014
Primary Completion Date : October 9, 2017
Study Completion Date : October 9, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Number of subjects diagnosed with CIN2+ cervical lesions [ Time Frame: At time of colposcopy ]
    Changes in number of subjects diagnosed with CIN2+ cervical lesions

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women referred for colposcopy after an abnormal screening test for prevention of cervical cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185599

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Sponsors and Collaborators
DySIS Medical Inc.

Responsible Party: DySIS Medical Inc.
ClinicalTrials.gov Identifier: NCT02185599     History of Changes
Other Study ID Numbers: IMPROVE-100
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by DySIS Medical Inc.:
cervical neoplasia
cervical dysplasia
cervical cancer

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type