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

Primary Purpose

Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cervical conization
ultrasonic surgical aspiration of the cervix
Sponsored by
University of Tennessee
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dysplasia focused on measuring cervical, dysplasia

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts 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

Sites / Locations

  • University of Tennessee College of Medicine
  • University of Tennessee Health Sciences Center

Outcomes

Primary Outcome Measures

Adequate treatment of cervical dysplasia

Secondary Outcome Measures

Full Information

First Posted
September 6, 2006
Last Updated
December 12, 2008
Sponsor
University of Tennessee
Collaborators
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00374114
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Tennessee
Collaborators
Integra LifeSciences Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dysplasia
Keywords
cervical, dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
cervical conization
Intervention Type
Procedure
Intervention Name(s)
ultrasonic surgical aspiration of the cervix
Primary Outcome Measure Information:
Title
Adequate treatment of cervical dysplasia

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen DePasquale, DO
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee College of Medicine
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
University of Tennessee Health Sciences Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

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

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