ColposcopyNCT00839475
Investigation of the Uterine Cervix Using CervicalMD
An observational study of Colposcopy, run by STI-Medical Systems.
Trial summary
The purpose of this study is to demonstrate the CervicalMD device's ability to collect digital imagery suitable for a colposcopy examination. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Colposcopy
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jul 2009
- 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 to 65 years
- 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
- Abnormal Pap smear
- 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: Investigational Study: Imaging the Uterine Cervix Using C30 Investigational Device
The purpose of this study is to demonstrate the CervicalMD device's ability to collect digital imagery suitable for a colposcopy examination.
- Conditions
- Colposcopy
- Keywords
- colposcopy, Cervical intraepithelial neoplasia, cervical cancer, cervical precancer
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionJul 2009
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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- STI-Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daron G Ferris, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839475
- Sponsor's protocol ID
- 2008-1
- Status last verified
- Mar 2010
- First submitted
- 5 Feb 2009
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigational Study: Imaging the Uterine Cervix Using C30 Investigational Device
- ClinicalTrials.gov ID
- NCT00839475
- Acronym / sponsor ID
- 2008-1
- Conditions
- Colposcopy
- Keywords
- colposcopy, Cervical intraepithelial neoplasia, cervical cancer, cervical precancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- STI-Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Feb 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.
The purpose of this study is to demonstrate the CervicalMD device's ability to collect digital imagery suitable for a colposcopy examination.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women identified with an abnormal Pap smear
Key inclusion criteria (5 listed)
- Female
- Negative Pregnancy test
- Abnormal Pap smear
- 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 24 Mar 2010.
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, MD 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 5 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 24 Mar 2010. 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 24 Mar 2010.