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

This study has been completed.
Integra LifeSciences Corporation
Information provided by:
University of Tennessee Identifier:
First received: September 6, 2006
Last updated: December 12, 2008
Last verified: December 2008
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00374114

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
Principal Investigator: Stephen DePasquale, DO University of Tennessee
  More Information Identifier: NCT00374114     History of Changes
Other Study ID Numbers: d34c09
Study First Received: September 6, 2006
Last Updated: December 12, 2008

Keywords provided by University of Tennessee:

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Pathologic Processes
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on September 21, 2017