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


N/A
18 Years
55 Years
Not Enrolling
Female
Cervical Dysplasia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adequate treatment of cervical dysplasia

Principal Investigator

Stephen DePasquale, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Tennessee

Authority:

United States: Institutional Review Board

Study ID:

d34c09

NCT ID:

NCT00374114

Start Date:

January 2004

Completion Date:

December 2006

Related Keywords:

  • Cervical Dysplasia
  • cervical
  • dysplasia
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia
  • Hyperplasia

Name

Location

University of Tennessee College of MedicineMemphis, Tennessee  38103
University of Tennessee Health Sciences CenterMemphis, Tennessee  38163