High Grade Cervical Intraepithelial NeoplasiaIMPROVE-COLPONCT02185599
IMproved PRactice Outcomes and Value Excellence in Colposcopy
An observational study of High Grade Cervical Intraepithelial Neoplasia, run by DySIS Medical Inc. at 46 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- High Grade Cervical Intraepithelial Neoplasia
- What is being tested?
- DySIS
- Type of treatment
- Medical device
- How many people
- 7,555 participants
- Where
- 46 sitesUnited States
- Study dates
- Sep 2014to 9 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women referred for colposcopy after an abnormal screening test for prevention of cervical cancer
Who may be able to join
- Females 21 years or older
- Able to give informed consent
- 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)
Show all 13Show fewer
- 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
Who cannot join
- Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer
- Pregnancy
- Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
- Referred for vulva/vaginal disease
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Unified Women's Clinical research-Alpharetta
Alpharetta, Georgia, 30005
Unified Women's Clinical Research-Atlanta
Atlanta, Georgia, 30342
Austin Area OB-Gyn
Austin, Texas, 78758
Dr Gregory Shifrin, OB/GYN, PC
Brooklyn, New York, 11229
Unified Women's Clinical Research-Cary
Cary, North Carolina, 27518
OB-GYN Associates
Cedar Rapids, Iowa, 52402
Nye Partners in Women's Health
Chicago, Illinois, 60611
Advocate Illinois Masonic Medical Center - Creticos Cancer Center
Chicago, Illinois, 60657
Coastal Bend Women's center
Corpus Christi, Texas, 78412
The Women's Center at Southview
Dayton, Ohio, 45459
Midwest Center for Women's Healthcare
Elgin, Illinois, 60123
Advanced Women's Healthcare Specialists, SC
Elk Grove Village, Illinois, 60007
Providea Health Partners, LLC
Evergreen Park, Illinois, 60805
Brodsky & Taylor, PLC
Ferndale, Michigan, 48220
Laura Bradford, MD
Fort Worth, Texas, 76104
Unified Women's Clinical Research-Gainesville
Gainesville, Florida, 32605
Northeast Georgia Physicians Group- Heritage
Gainesville, Georgia, 30501
Unified Women's Clinical Research-Greensboro
Greensboro, North Carolina, 27401
Unified Women's Clinical Research- Central Carolina
Greensboro, North Carolina, 27408
NJ Gynecological Institute
Hackensack, New Jersey, 07601
Women's Wellness World
Hazel Crest, Illinois, 60429
Lakeside Ob/Gyn-Northeast Georgia Physician Group
Hoschton, Georgia, 30548
Margaret A. Smollen, MD, PC
Iowa City, Iowa, 52245
Las Colinas OBGyn
Irving, Texas, 75062
MacArthur OB/GYN
Irving, Texas, 75062
North Florida OB GYN Associates, PA
Jacksonville, Florida, 32216
Advanced Women's Wellness
Katy, Texas, 77450
Osceola Ob-Gyn, PA
Kissimmee, Florida, 34741
Zeid Women's Health Center
Longview, Texas, 75601
Craig Ranch Ob/Gyn
McKinney, Texas, 75070
Women's Healthcare of Illinois
Mokena, Illinois, 60448
Lyndhurst Clinical Research- Mt Airy
Mount Airy, North Carolina, 27030
The Advanced Gynecologic Surgery Institute
Naperville, Illinois, 60540
Women's Center for Health
Naperville, Illinois, 60540
Southwest Women's Healthcare Associates
Olympia Fields, Illinois, 60461
Women's Healthcare of Princeton, LLC
Princeton, New Jersey, 08540
Advanced Ob-Gyn Associates
Richardson, Texas, 75082
Piedmont Preferred Women's Healthcare Associates
Ridgeway, Virginia, 24148
Dr DeLeon's Women's Healthcare
Rowlett, Texas, 75088
Arizona Oncology
Scottsdale, Arizona, 85258
New Beginnings, OB/GYN
Springfield, New Jersey, 07081
Physicians & Surgeons for Women, Inc
Springfield, Ohio, 45505
The University of Toledo
Toledo, Ohio, 43614
Downriver Obstetrics & Gynecology
Trenton, Michigan, 48183
Hinsdale & Oak Brook Women's Clinic
Willowbrook, Illinois, 60527
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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.
Read the 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.
- Being tested
- DySIS
- Keywords
- colposcopy, CIN, cervical neoplasia, cervical dysplasia, cervical cancer, CIN2+
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DySISDevice
Colposcopy performed with the DySIS digital colposcope
| Study group | Role | What they receive |
|---|---|---|
| Colposcopy with DySIS | The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS. Receives: Device: DySIS | |
| Standard colposcopy | The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects diagnosed with CIN2+ cervical lesions
Changes in number of subjects diagnosed with CIN2+ cervical lesions
Measured: At time of colposcopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startSep 2014
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 7,555 participants (actual)
Sponsor and investigators
- Lead sponsor
- DySIS Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185599
- Sponsor's protocol ID
- IMPROVE-100
- Acronym
- IMPROVE-COLPO
- Status last verified
- Mar 2020
- First submitted
- 4 Jul 2014
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMproved PRactice Outcomes and Value Excellence in Colposcopy
- ClinicalTrials.gov ID
- NCT02185599
- Acronym / sponsor ID
- IMPROVE-COLPO / IMPROVE-100
- Keywords
- colposcopy, CIN, cervical neoplasia, cervical dysplasia, cervical cancer, CIN2+
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,555 participants (actual)
- Lead sponsor
- DySIS Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colposcopy with DySIS | – | Device: DySISThe prospective arm will recruit patients referred for colposcopy and will be examined using DySIS. |
| Standard colposcopy | – | –The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women referred for colposcopy after an abnormal screening test for prevention of cervical cancer
Key inclusion criteria (13 listed)
- Females 21 years or older
- Able to give informed consent
- Referred for colposcopy with a screening test result that indicates the need for a colposcopy, based on guidelines and practice:
Key exclusion criteria (4 listed)
- Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer
- Pregnancy
- Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
- Referred for vulva/vaginal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DySISColposcopy performed with the DySIS digital colposcope | Device | Colposcopy with DySIS |
Primary outcome
Number of subjects diagnosed with CIN2+ cervical lesions
Time frame: At time of colposcopy
Changes in number of subjects diagnosed with CIN2+ cervical lesions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Cervical Intraepithelial Neoplasia, run by DySIS Medical Inc. at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects diagnosed with CIN2+ cervical lesions (time frame: At time of colposcopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.