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

DySIS Medical

Status: Completed

Conditions: High Grade Cervical Intraepithelial Neoplasia

Treatments: Device: DySIS

Study type: Observational

Funder types: Industry

Identifiers

NCT02185599

IMPROVE-100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,555 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

7,555 participants in 2 patient groups

Colposcopy with DySIS

Description:

The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.

Treatment:

Device: DySIS

Standard colposcopy

Description:

The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope.