CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 103 enrolled
Drug / intervention
Straight Wire Excision of Transformation Zone +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00995020
NCT00995020Phase 3Completed
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A Study of Two Cone Biopsy Techniques For Women With Cervical Pre-Invasive Disease. LLETZ Cone and SWETZ.

Oswaldo Cruz Foundation·interventional·Posted Oct 14, 2009·Updated Jul 10, 2015

In Brief

A Phase 3 clinical trial evaluating Straight Wire Excision of Transformation Zone and Large Loop Excision of Transformation Zone (cone biopsy) for Cervical Intraepithelial Neoplasia. Completed, enrolled 103 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Intraepithelial Neoplasia
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 14, 2009
Enrollment StartNov 1, 1999
Primary CompletionDec 1, 2004
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 16.7 years ago

Interventions

Straight Wire Excision of Transformation Zoneprocedure

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.

Large Loop Excision of Transformation Zone (cone biopsy)procedure

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.