Clinical trial · Interventional
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
NCT02875561CI-TRIAL-00071462completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Intraepithelial Neoplasia (VIN) | Vulvar Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CO2 Laser Ablation | Device | — | UNRESOLVED |
| Sonopet Ultrasonic Aspirator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sonopet Ultrasonic Aspirator
- description
- Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
- interventionNames
- Device: Sonopet Ultrasonic Aspirator
- type
- EXPERIMENTAL
- label
- CO2 Laser Ablation
- description
- Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
- interventionNames
- Device: CO2 Laser Ablation
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Women 18-89 years old * Women diagnosed with high-grade VIN (diagnosed by pathology) * Women referred for vulva sparing treatment for dysplasia * Women available for follow-up of treatment for 12 months Exclusion Criteria: * Women who are pregnant * Women with low-grade VIN dysplasia (diagnosed by pathology) * Women with vaginal intraepithelial neoplasia(VAIN) * Women requiring vulvectomy for treatment * Women unable to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.