Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue|
- Number of patients with adequate visualization and access to cervix or vaginal vault [ Time Frame: At time of speculum exam ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409902
|United States, Florida|
|Tampa, Florida, United States, 33549|
|Principal Investigator:||Erich Wyckoff, M||University of South Florida|