ColposcopyNCT00941512
High Resolution Digital Imaging of the Uterine Cervix
An observational study of Colposcopy, run by STI-Medical Systems.
Trial summary
This study was designed to gather digital pictures of the cervix and correlate it to its histopathology, and then use those relationships to teach a computer how to objectively find cervical dysplasia and cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Colposcopy
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Dec 2005
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women identified with an abnormal Pap smear
Who may be able to join
- Female
- Negative pregnancy test
- 18 years and older
- Presence of a cervix
Who cannot join
- Pregnant
- Absence of a cervix
- Less than 18 years old
- Male
About this study
Official title: Investigation to Correlate High Resolution Digital Images of the Uterine Cervix With Histopathology
This study was designed to gather digital pictures of the cervix and correlate it to its histopathology, and then use those relationships to teach a computer how to objectively find cervical dysplasia and cancer.
- Conditions
- Colposcopy
- Keywords
- Colposcopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startApr 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColposcopyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- STI-Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto National de Edfermedades Neoplasicas, Eisenhower Army Medical Center
- Investigators
- Daron G Ferris, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941512
- Sponsor's protocol ID
- 2005-1
- Status last verified
- Jul 2009
- First submitted
- 15 Jul 2009
- Last updated
- 17 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation to Correlate High Resolution Digital Images of the Uterine Cervix With Histopathology
- ClinicalTrials.gov ID
- NCT00941512
- Acronym / sponsor ID
- 2005-1
- Conditions
- Colposcopy
- Keywords
- Colposcopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- STI-Medical SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Instituto National de Edfermedades Neoplasicas, Eisenhower Army Medical Center
- Study start
- Apr 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 17 Jul 2009 (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.
This study was designed to gather digital pictures of the cervix and correlate it to its histopathology, and then use those relationships to teach a computer how to objectively find cervical dysplasia and cancer.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women identified with an abnormal Pap smear
Key inclusion criteria (4 listed)
- Female
- Negative pregnancy test
- 18 years and older
- Presence of a cervix
Key exclusion criteria (4 listed)
- Pregnant
- Absence of a cervix
- Less than 18 years old
- Male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 17 Jul 2009.
Related trials for Colposcopy
Not yet recruitingObservational study
Clinical Audit of Cervical Cytology Services in an Early Cancer Detection Unit
Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasms
RecruitingObservational study
Vaginal Wall Retraction Using VuSleeve
Adult Females
Not yet recruiting
Embodied Conversational Agents for CervicalCancer Screening Abnormalities
Cervical Cancer Screening
Recruiting
Improving Diagnostics in Cervical Dysplasia
Cervical Cancer
Not yet recruitingObservational study
VIA Versus Colposcopy
Cervical Intraepithelial Neoplasia (CIN), Cervicitis
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.
Daron G Ferris principal investigator
Augusta University
Questions about this trial
What is this clinical trial studying?
An observational study of Colposcopy, run by STI-Medical Systems.
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 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 17 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 17 Jul 2009.