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

December 12, 2008 updated by: University of Tennessee
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University of Tennessee College of Medicine
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adequate treatment of cervical dysplasia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

Integra LifeSciences Corporation

Investigators

  • Principal Investigator: Stephen DePasquale, DO, University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 6, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (Estimate)

September 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 15, 2008

Last Update Submitted That Met QC Criteria

December 12, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • d34c09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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