Cervical Pre-cancerNCT02477124
A See and Treat Paradigm for Cervical Pre-cancer
A study testing transvaginal digital colposcope (TVDC) in people with Cervical Pre-cancer, run by Duke University at 5 sites in 5 countries.
Trial summary
The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Cervical Pre-cancer
- What is being tested?
- transvaginal digital colposcope (TVDC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Sep 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
- Age 25 and greater
- Patients of all ethnic backgrounds will be included.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Children and subjects under 25.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
Duke University Medical Center
Durham, North Carolina, 27708
About this study
The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
- Conditions
- Cervical Pre-cancer
- Being tested
- transvaginal digital colposcope (TVDC), Standard of care screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal digital colposcope (TVDC)Device
TVDC is a miniature colposcope used to obtain images of cervical tissue.
Standard of care screeningOther
Standard of care screening varies from institution to institution but is either visual inspection with the naked eye, colposcopy, or visual inspection with a camera or microscope
| Study group | Role | What they receive |
|---|---|---|
| transvaginal digital colposcope (TVCD) | Active comparator | Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. Receives: Device: transvaginal digital colposcope (TVDC) |
| standard of care screening | Active comparator | Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. Receives: Other: Standard of care screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree
Measured: Up to approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Pre-cancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nirmala Ramanujam, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477124
- Sponsor's protocol ID
- Pro00052865
- Status last verified
- May 2023
- First submitted
- 12 Jun 2015
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A See and Treat Paradigm for Cervical Pre-cancer
- ClinicalTrials.gov ID
- NCT02477124
- Acronym / sponsor ID
- Pro00052865
- Conditions
- Cervical Pre-cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transvaginal digital colposcope (TVCD) | Active comparator | Device: transvaginal digital colposcope (TVDC)Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. |
| standard of care screening | Active comparator | Other: Standard of care screeningEach enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
- Age 25 and greater
- Patients of all ethnic backgrounds will be included.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (1 listed)
- Children and subjects under 25.
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 |
|---|---|---|
| transvaginal digital colposcope (TVDC)TVDC is a miniature colposcope used to obtain images of cervical tissue. | Device | transvaginal digital colposcope (TVCD) |
| Standard of care screeningStandard of care screening varies from institution to institution but is either visual inspection with the naked eye, colposcopy, or visual inspection with a camera or microscope | Other | standard of care screening |
Primary outcome
Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree
Time frame: Up to approximately 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nirmala Ramanujam, PhD principal investigator
Duke University
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transvaginal digital colposcope (TVDC) in people with Cervical Pre-cancer, run by Duke University at 5 sites in 5 countries.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, India, Peru, Tanzania, Zambia. 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?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree (time frame: Up to approximately 10 minutes). 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 18 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.