Phase 3
Completed N=103
Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion
Source: ClinicalTrials.gov NCT00995020 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Endocervical Margin Not Free of Disease. — 8; 10 participants
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.
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 | — |
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
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. Informational only — not medical advice.