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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervical Dysplasia

Keywords

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cervical dysplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cervical conization

Intervention Type PROCEDURE

ultrasonic surgical aspiration of the cervix

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Stephen DePasquale, DO

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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University of Tennessee College of Medicine

Chattanooga, Tennessee, United States

Site Status

University of Tennessee Health Sciences Center

Memphis, Tennessee, United States