A Comparison of a Sheathed to a Standard Speculum for Visualization of the Cervix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to estimate if a novel sheathed speculum provides improved visualization of the cervix compared to a standard ("non sheathed") speculum, and to estimate if the sheathed speculum causes less discomfort during the examination.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue

NCT01409902

Vaginal Prolapse

COMPLETED

A Novel Smart Speculum Versus a Standard Speculum for Easy Visualisation of the Cervix and Performing Remote Cervical Cancer Screening

NCT06359431

Cervical Cancer

NOT_YET_RECRUITING NA

Using a Sheathed Speculum to Visualize and Access the Cervix in Women With Excessive Vaginal Tissue

NCT00595166

Healthy

TERMINATED

The Use of a Novel Vaginal Speculum for Cervical Cancer Screening in Sunrise Community Health Patients

NCT06496295

Cervical Cancer Screening

ENROLLING_BY_INVITATION

Investigation of the Uterine Cervix Using CervicalMD

NCT00839475

Colposcopy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized trial where physician investigators will perform clinically indicated vaginal speculum examinations using either a sheathed or a standard plastic speculum, to determine which speculum provides the best visualization of the cervix. As a secondary outcome, study participants will record their pain level on a 10-cm visual analogue scale.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Comparison of a Sheathed Versus Standard Plastic Speculum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sheathed speculum

Investigators will perform a vaginal speculum examination with either a sheathed or a standard ("non sheathed" speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.

Group Type ACTIVE_COMPARATOR

Sheathed speculum examination

Intervention Type PROCEDURE

Standard speculum examination

Investigators will perform a vaginal speculum examination with either a standard or a sheathed speculum in a randomized comparison to estimate the degree of cervical visualization and subject pain perception.

Group Type ACTIVE_COMPARATOR

Standard speculum examination

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sheathed speculum examination

Intervention Type PROCEDURE

Standard speculum examination

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

speculum sheath ClearSpec

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Undergoing clinically indicated vaginal speculum examination.
* Subject has had at least 1 prior vaginal deliver \> 20 weeks gestational age.
* Able to read and speak English.

Exclusion Criteria

* Active vulvar lesions or conditions (sexually transmitted infections, vestibulodynia, candida, vaginitis, or vulvar dermatologic condition).
* Menopausal or using hormone replacement therapy.
* Genital atrophy.
* Chronic pelvic pain, dyspareunia, or interstitial cystitis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No