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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by DySIS Medical Inc.
Sponsor:
Information provided by (Responsible Party):
DySIS Medical Inc.
ClinicalTrials.gov Identifier:
NCT02185599
First received: July 4, 2014
Last updated: March 10, 2017
Last verified: March 2017
  Purpose

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 Intervention
High Grade Cervical Intraepithelial Neoplasia
Device: DySIS

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: IMproved PRactice Outcomes and Value Excellence in Colposcopy

Resource links provided by NLM:


Further study details as provided by DySIS Medical Inc.:

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


Estimated Enrollment: 11000
Study Start Date: September 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02185599

  Show 44 Study Locations
Sponsors and Collaborators
DySIS Medical Inc.
  More Information

Responsible Party: DySIS Medical Inc.
ClinicalTrials.gov Identifier: NCT02185599     History of Changes
Other Study ID Numbers: IMPROVE-100
Study First Received: July 4, 2014
Last Updated: March 10, 2017

Keywords provided by DySIS Medical Inc.:
colposcopy
CIN
cervical neoplasia
cervical dysplasia
cervical cancer
CIN2+

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

ClinicalTrials.gov processed this record on March 29, 2017