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Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion

NCT00995020 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2015-07-10

Study results available
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Summary

The purpose of this trial is to determine whether SWETZ (Straight Wire Excision of Transformation Zone) is a superior alternative to LLETZ cone (Large Loop Excision of Transformation Zone cone biopsy) in the management of pre-invasive endocervical disease.

SWETZ is a new cone biopsy procedure performed with a straight wire electrode and it will be compared to LLETZ cone, which is performed with a large loop electrode.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

PROCEDURE

Straight Wire Excision of Transformation Zone

Straight wire excision of transformation zone is a electrosurgical conization method,which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.

PROCEDURE

Large Loop Excision of Transformation Zone (cone biopsy)

LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20-25 mm depth. The loop is applied to the cervix outside the lateral margin of TZ and brought slowly to the controlateral TZ margin.

Sponsors & Collaborators

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • WALTER PRENDIVILLE, PhD · British Society of Colposcopy

  • WALTER PRENDIVILLE, PhD · International Federation of Cervical Pathology and Colposcopy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-11-30
Primary Completion
2004-12-31
Completion
2010-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995020 on ClinicalTrials.gov