Brief Title
A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia
Official Title
A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for 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.
Study Type
Interventional
Primary Outcome
Adequate treatment of cervical dysplasia
Condition
Cervical Dysplasia
Intervention
cervical conization
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
20
Start Date
January 2004
Completion Date
December 2006
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Stephen DePasquale, DO, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00374114
Organization ID
d34c09
Study Sponsor
University of Tennessee
Collaborators
Integra LifeSciences Corporation
Study Sponsor
Stephen DePasquale, DO, Principal Investigator, University of Tennessee
Verification Date
December 2008