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NCT00595166 · ClinicalTrials.gov registry record
Using a Sheathed Speculum to Visualize and Access the Cervix in Women With Excessive Vaginal Tissue
A clinical trial, sponsored by University of South Florida.
- Terminated
- Registry status
- 38
- Enrollment target
NCT00595166: Clinical Trial study, sponsored by University of South Florida.
NCT00595166 is a clinical trial that was terminated before completion, run by University of South Florida. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00595166 was terminated before completion, sponsored by University of South Florida.
- TERMINATED
- Registry status
- 38 participants
- Enrollment target
Study Summary
This new invention addresses the inadequate and incomplete visualization of the cervix in patients with excessive vaginal tissue. In general these patients are obese, or are multiparous with a history of multiple vaginal deliveries. A vaginal speculum is a vital medical instrument that allows a health care provider to visualize the interior aspects of the vagina, as well as the distal portion of the uterus, the cervix. It is composed of 2 blades assembled together and held by a handle. The blades and the handle form a 90 degree-angle. As the user holds the handle, a lever attached to the top blade allows it to open away from the inferior blade. When the instrument is inserted into the vagina, the two blades are separated in order to keep the anterior and posterior vaginal walls apart. In that position, the cervix and the walls of the vagina can be seen if the patient does not have an excess of loose vaginal tissue. However, in patients with excessive tissue, the sidewalls of the vagina simply collapse toward the midline between the blades because of the fact that no part of the speculum is in direct contact with the lateral walls of the vagina. This collapse prevents the complete and crucial visualization of the cervix for purposes of cervical cultures, pap smears, visual assessment of ruptured membranes, visual assessment of the degree of dilation, biopsies, and other procedures requiring access to the cervix or the uterus. When clinicians face this dilemma, they may try the largest speculum available, and will open it as wide as possible in order to keep the lateral walls apart. Most often, they have to improvise by cutting the tip of a condom, or the thumb off a glove, or they use a sterile lateral-wall retractor. These other creative solutions can take several minutes of precious times and may still result in an inadequate visualization and suboptimal access. A vaginal speculum sheath for retaining vaginal tissue in a lateral direction conforms to a pair of
Interventions
- DEVICE Vaginal Speculum Sheath
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2007-06 |
| Est. Completion | 2013-03 |
Why NCT00595166 stopped before completion
NCT00595166 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Vaginal Speculum Sheath is the first listed.
NCT00595166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00595166 about?
NCT00595166 is a clinical study titled "Using a Sheathed Speculum to Visualize and Access the Cervix in Women With Excessive Vaginal Tissue". This new invention addresses the inadequate and incomplete visualization of the cervix in patients with excessive vaginal tissue. In general these patients are obese, or are multiparous with a history of multiple vaginal deliveries. A vaginal speculum is a vital medical instrument that allows a hea...
What is the current status of trial NCT00595166?
This trial is currently terminated. The enrollment target is 38 participants. The study started on 2007-06. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00595166?
The interventions under investigation include: Vaginal Speculum Sheath (DEVICE).
Who is sponsoring clinical trial NCT00595166?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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