IMproved PRactice Outcomes and Value Excellence in Colposcopy

High Grade Cervical Intraepithelial Neoplasia Clinical Trial

— IMPROVE-COLPO  

Official title:

IMproved PRactice Outcomes and Value Excellence in Colposcopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185599
• Other study ID #: IMPROVE-100
• Status: Completed
• Start date: September 2014
• Est. completion date: October 9, 2017

Study information

• Verified date: March 2020
• Source: DySIS Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7555
• Est. completion date: October 9, 2017
• Est. primary completion date: October 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• High Grade Cervical Intraepithelial Neoplasia
• Neoplasms

Intervention

Device:
• DySIS
Colposcopy performed with the DySIS digital colposcope

Locations

Country	Name	City	State
United States	Unified Women's Clinical research-Alpharetta	Alpharetta	Georgia
United States	Unified Women's Clinical Research-Atlanta	Atlanta	Georgia
United States	Austin Area OB-Gyn	Austin	Texas
United States	Dr Gregory Shifrin, OB/GYN, PC	Brooklyn	New York
United States	Unified Women's Clinical Research-Cary	Cary	North Carolina
United States	OB-GYN Associates	Cedar Rapids	Iowa
United States	Advocate Illinois Masonic Medical Center - Creticos Cancer Center	Chicago	Illinois
United States	Nye Partners in Women's Health	Chicago	Illinois
United States	Coastal Bend Women's center	Corpus Christi	Texas
United States	The Women's Center at Southview	Dayton	Ohio
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	Brodsky & Taylor, PLC	Ferndale	Michigan
United States	Laura Bradford, MD	Fort Worth	Texas
United States	Northeast Georgia Physicians Group- Heritage	Gainesville	Georgia
United States	Unified Women's Clinical Research-Gainesville	Gainesville	Florida
United States	Unified Women's Clinical Research- Central Carolina	Greensboro	North Carolina
United States	Unified Women's Clinical Research-Greensboro	Greensboro	North Carolina
United States	NJ Gynecological Institute	Hackensack	New Jersey
United States	Women's Wellness World	Hazel Crest	Illinois
United States	Lakeside Ob/Gyn-Northeast Georgia Physician Group	Hoschton	Georgia
United States	Margaret A. Smollen, MD, PC	Iowa City	Iowa
United States	Las Colinas OBGyn	Irving	Texas
United States	MacArthur OB/GYN	Irving	Texas
United States	North Florida OB GYN Associates, PA	Jacksonville	Florida
United States	Advanced Women's Wellness	Katy	Texas
United States	Osceola Ob-Gyn, PA	Kissimmee	Florida
United States	Zeid Women's Health Center	Longview	Texas
United States	Craig Ranch Ob/Gyn	McKinney	Texas
United States	Women's Healthcare of Illinois	Mokena	Illinois
United States	Lyndhurst Clinical Research- Mt Airy	Mount Airy	North Carolina
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	Women's Healthcare of Princeton, LLC	Princeton	New Jersey
United States	Advanced Ob-Gyn Associates	Richardson	Texas
United States	Piedmont Preferred Women's Healthcare Associates	Ridgeway	Virginia
United States	Dr DeLeon's Women's Healthcare	Rowlett	Texas
United States	Arizona Oncology	Scottsdale	Arizona
United States	New Beginnings, OB/GYN	Springfield	New Jersey
United States	Physicians & Surgeons for Women, Inc	Springfield	Ohio
United States	The University of Toledo	Toledo	Ohio
United States	Downriver Obstetrics & Gynecology	Trenton	Michigan
United States	Hinsdale & Oak Brook Women's Clinic	Willowbrook	Illinois
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
DySIS Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects diagnosed with CIN2+ cervical lesions	Changes in number of subjects diagnosed with CIN2+ cervical lesions	At time of colposcopy