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

Overview

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 Type

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

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.

Interventions

  • Procedure: cervical conization
  • Procedure: ultrasonic surgical aspiration of the cervix

Clinical Trial Outcome Measures

Primary Measures

  • Adequate treatment of cervical dysplasia

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Tennessee
  • Collaborator
    • Integra LifeSciences Corporation
  • Overall Official(s)
    • Stephen DePasquale, DO, Principal Investigator, University of Tennessee

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