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

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ClinicalTrials.gov Identifier: NCT00374114
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : December 15, 2008
Sponsor:
Collaborator:
Integra LifeSciences Corporation
Information provided by:
University of Tennessee

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.

Condition or disease Intervention/treatment Phase
Cervical Dysplasia Procedure: cervical conization Procedure: ultrasonic surgical aspiration of the cervix Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : January 2004
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adequate treatment of cervical dysplasia


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00374114     History of Changes
Other Study ID Numbers: d34c09
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: December 15, 2008
Last Verified: December 2008

Keywords provided by University of Tennessee:
cervical
dysplasia

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