NCT01090635

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 4, 2011

Status Verified

February 1, 2011

Enrollment Period

11 months

First QC Date

March 18, 2010

Last Update Submit

February 3, 2011

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical Intraepithelial Neoplasia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy non-pregnant females over 18 years old.

You may qualify if:

  • Healthy Female
  • years old or older
  • Not pregnant
  • Ability to give consent

You may not qualify if:

  • Male
  • Less than 18 years old
  • Pregnant or suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Nathan Fujita

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Study Officials

  • Nathan Fujita, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 22, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 4, 2011

Record last verified: 2011-02

Locations

US(1)