Cervical Dysplasia
Conditions
Keywords
cervical, dysplasia
Brief summary
Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical dysplasia without compromising the integrity of the cervix in reproductive age women.
Detailed description
Women age 18 to 55 years of age with Cervical Intraepithelial Neoplasia 2 or 3 on colposcopy with a negative EndoCervical Curettage are enrolled in a pilot study comparing ultrasonic surgical aspiration and traditional cervical excision procedure for the treatment of cervical dysplasia. In this pilot study, the patients serve as their own control group. Prior to receiving the traditional treatment for cervical dysplasia consisting of Cold Knife Conization with EndoCervical Curettage, each patient's cervix is treated with ultrasonic surgical aspiration. The aspirate is sent to pathology and the results compared with the findings from the cervical cone biopsy. The patients then are followed with Liquid-based Cytology pap smears every 4 to 6 months until completion of the study enrollment/treatment period.
Interventions
PROCEDUREcervical conization
PROCEDUREultrasonic surgical aspiration of the cervix
Sponsors
Integra LifeSciences Corporation
University of Tennessee
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* cervical intraepithelial neoplasia II or III * negative endocervical curettage * not pregnant * cervical conization is part of treatment plan
Exclusion criteria
* positive endocervical curettage * pregnant * medically unable to undergo surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate treatment of cervical dysplasia | — |
Countries
United States
Outcome results
None listed