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

This study has been completed.
Sponsor:
Collaborator:
Integra LifeSciences Corporation
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00374114
First received: September 6, 2006
Last updated: December 12, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
Cervical Dysplasia
Procedure: cervical conization
Procedure: ultrasonic surgical aspiration of the cervix

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Adequate treatment of cervical dysplasia

Estimated Enrollment: 20
Study Start Date: January 2004
Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374114

Locations
United States, Tennessee
University of Tennessee College of Medicine
Chattanooga, Tennessee, United States, 37403
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
Integra LifeSciences Corporation
Investigators
Principal Investigator: Stephen DePasquale, DO University of Tennessee
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00374114     History of Changes
Other Study ID Numbers: d34c09
Study First Received: September 6, 2006
Last Updated: December 12, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
cervical
dysplasia

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 26, 2014