Uterine Cervical NeoplasmsNCT01090635
Imaging the Uterine Cervix - UltraSightHD™
An observational study of Uterine Cervical Neoplasms, run by STI-Medical Systems at 1 site in United States.
Trial summary
The purpose of this study is to investigate the performance ability of the UltraSightHD™. The instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy non-pregnant females over 18 years old.
Who may be able to join
- Healthy Female
- 18 years old or older
- Not pregnant
- Ability to give consent
Who cannot join
- Male
- Less than 18 years old
- Pregnant or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the performance ability of the UltraSightHD™. The instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. The information gathered from this study will provide data that will be used to determine which settings provide the best imaging outcome for the cervix for a simple screening instrument. Further, this information will serve as the foundation in the development of more advanced follow-on imaging devices.
The primary objectives of this study are to:
- Determine if the light source provides sufficient illumination of the cervix.
- Assess focus and overall image quality.
- Assess the functionality and ergonomics of the instrument's design.
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Cervical Intraepithelial Neoplasia
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- STI-Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nathan Fujita, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090635
- Sponsor's protocol ID
- 2010-1
- Status last verified
- Feb 2011
- First submitted
- 18 Mar 2010
- Last updated
- 4 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging the Uterine Cervix - UltraSightHD™
- ClinicalTrials.gov ID
- NCT01090635
- Acronym / sponsor ID
- 2010-1
- Conditions
- Uterine Cervical Neoplasms
- Keywords
- Cervical Intraepithelial Neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- STI-Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Mar 2010 (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 investigate the performance ability of the UltraSightHD™. The instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. The information gathered from this study will provide data that will be used to determine which settings provide the best imaging outcome for the cervix for a simple screening instrument. Further, this information will serve as the foundation in the development of more advanced follow-on imaging devices.
The primary objectives of this study are to:
- Determine if the light source provides sufficient illumination of the cervix.
- Assess focus and overall image quality.
- Assess the functionality and ergonomics of the instrument's design.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy non-pregnant females over 18 years old.
Key inclusion criteria (4 listed)
- Healthy Female
- 18 years old or older
- Not pregnant
- Ability to give consent
Key exclusion criteria (3 listed)
- Male
- Less than 18 years old
- Pregnant or suspected pregnancy
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 4 Feb 2011.
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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.
Nathan Fujita, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cervical Neoplasms, run by STI-Medical Systems at 1 site 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 4 inclusion and 3 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 4 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 4 Feb 2011.