Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT01409902
Status:
COMPLETED
Last Update Posted:
2013-04-23
First Post:
2011-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
Sponsor:
University of South Florida
Organization:
Study Overview
Official Title:
Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
Status:
COMPLETED
Status Verified Date:
2013-04
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 main objective of the study is to assess the effectiveness of the sheathed speculum in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue.
The secondary objective is to rate the patient's comfort evaluation during the sheathed speculum examination.
The secondary objective is to rate the patient's comfort evaluation during the sheathed speculum examination.
Detailed Description:
This is a descriptive clinical trial designed to assess the efficacy of a sheathed speculum in providing adequate visualization and access to the cervix in women with excessive vaginal tissue. Eligible, consented subjects who fail their initial speculum examination (because their cervix is not visualized due to the collapse of loose lateral vaginal walls) will have a sheathed speculum examination instead of the standard-of-care exam whereby the clinician fabricates a solution at the bedside (condom with tip cut placed on speculum, concomitantly using an additional instrument like a lateral-wall retractor, glove with tip of thumb placed over the speculum, using the largest speculum available)
Study Oversight
Has Oversight DMC:
True
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?: