NCT00374114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 15, 2008

Status Verified

December 1, 2008

First QC Date

September 6, 2006

Last Update Submit

December 12, 2008

Conditions

Cervical Dysplasia

Keywords

cervicaldysplasia

Outcome Measures

Primary Outcomes (1)

  • Adequate treatment of cervical dysplasia

Interventions

cervical conizationPROCEDURE
ultrasonic surgical aspiration of the cervixPROCEDURE

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • cervical intraepithelial neoplasia II or III
  • negative endocervical curettage
  • not pregnant
  • cervical conization is part of treatment plan

You may not qualify if:

  • positive endocervical curettage
  • pregnant
  • medically unable to undergo surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Tennessee College of Medicine

Chattanooga, Tennessee, 37403, United States

Location

University of Tennessee Health Sciences Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Conization

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Stephen DePasquale, DO

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

January 1, 2004

Study Completion

December 1, 2006

Last Updated

December 15, 2008

Record last verified: 2008-12

Locations

US(2)