Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-28 @ 3:37 AM
Study NCT ID:
NCT01090635
Status:
COMPLETED
Last Update Posted:
2011-02-04
First Post:
2010-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging the Uterine Cervix - UltraSightHD™
Sponsor:
STI-Medical Systems
Organization:
Study Overview
Official Title:
Imaging the Uterine Cervix - UltraSightHD™
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: