A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia

University of Tennessee

Status: Completed

Conditions: Cervical Dysplasia

Treatments: Procedure: ultrasonic surgical aspiration of the cervix; Procedure: cervical conization

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00374114

d34c09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)