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NCT00374114 Clinical Trial

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

Cervical Dysplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00374114
Other study ID # d34c09
Secondary ID
Status Completed
Phase N/A
First received September 6, 2006
Last updated December 12, 2008
Start date January 2004
Est. completion date December 2006

Study information
Verified date December 2008
Source University of Tennessee
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• cervical conization

• ultrasonic surgical aspiration of the cervix

Locations
Country Name City State
United States University of Tennessee College of Medicine Chattanooga Tennessee
United States University of Tennessee Health Sciences Center Memphis Tennessee

Sponsors (2)
Lead Sponsor Collaborator
University of Tennessee Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adequate treatment of cervical dysplasia
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