Phase 3 N=103 Randomized Single-blind Treatment

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

Cervical Intraepithelial Neoplasia

Bottom Line

View on ClinicalTrials.gov: NCT00995020 ↗

Enrolled (actual)

103

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcome: Primary: Endocervical Margin Not Free of Disease. — 8; 10 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Straight Wire Excision of Transformation Zone (Procedure); Large Loop Excision of Transformation Zone (cone biopsy) (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Oswaldo Cruz Foundation
Primary completion: Dec 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Endocervical Margin Not Free of Disease.	8; 10	—
SECONDARY Time Spent to Perform the Procedure	13.5; 23.2	—

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.

Eligibility Criteria

Inclusion Criteria

Incompletely visible transformation zone in women with High grade Squamous Intraepithelial Lesion (HSIL)
Suspicion of microinvasive carcinoma or occult invasive carcinoma
Suspicion of glandular disease

Exclusion Criteria

Pregnancy
Coagulation disorders
Cervicitis were present
Refusal to participate in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00995020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.