Clinical trial · Interventional
Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device
Comparison of Cervical Intraepithelial Neoplasia 2/3 Treatment Outcomes With a Portable LMIC-adapted Thermal Ablation Device vs. Gas-based Cryotherapy
- 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 purpose of this academic-industrial partnership will be to compare two thermoablation modalities using devices adapted to low and middle income countries (LMICs) to traditional CO2-based cryotherapy for the treatment of cervical precancer. The investigators will investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.
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 |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiple Tip Thermoablation | Device | — | UNRESOLVED |
| Single Tip Thermoablation | Device | — | UNRESOLVED |
| Standard C02 Cryotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard C02 Cryotherapy
- description
- Standard therapy using carbon dioxide for freezing of tissue
- interventionNames
- Device: Standard C02 Cryotherapy
- type
- EXPERIMENTAL
- label
- Single Tip Thermoablation
- description
- Thermoablator outfitted with a 19mm conical tip
- interventionNames
- Device: Single Tip Thermoablation
- type
- EXPERIMENTAL
- label
- Multiple Tip Thermoablation
- description
- Thermoablator outfitted with detachable probes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria for inclusion * Women aged 18 and older * Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified * Willing and able to provide informed consent * Willing and able to provide permanent or reliable address Criteria for exclusion * Pregnant or plans to become pregnant during study * History of total hysterectomy (verified by medical record or pelvic evaluation) * Previous surgery destructive to the cervix within the last 5 years * Patient not eligible for cryotherapy or thermoablation (lesion \>75% of cervix, lesion extends into canal or there is suspicion for invasive cancer) * Cervix shape disfigured or hard to reach
References
Publications (0)
Data not yet available