Clinical trial · Interventional
An Innovative Treatment for Cervical Precancer (UH3)
A Randomized Controlled Trial Comparing Cure Rates of Cervical Intraepithelial Neoplasia Grade 2 and Higher (CIN2+) Treated With CO2-based Cryotherapy, CropPen, and Thermoablation (UH3)
- 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 compare the CryoPen® and thermoablator to traditional CO2-based cryotherapy for the treatment of cervical precancer in low and middle income countries (LMICs) and 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 |
|---|---|---|---|
| CO2 standard therapy | Device | — | UNRESOLVED |
| CryoPen | Device | — | UNRESOLVED |
| Thermocoagulator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- CO2 standard therapy
- description
- Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze
- interventionNames
- Device: CO2 standard therapy
- type
- EXPERIMENTAL
- label
- CryoPen
- description
- Single freeze treatment consists of one five-minute freeze
- interventionNames
- Device: CryoPen
- type
- EXPERIMENTAL
- label
- Thermocoagulator
- description
- Thermoablation for 60-seconds at 100 degrees Celsius
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 (lesion \>75% of cervix, lesion extends into canal or there is suspicion for invasive cancer) * Cervix shape disfigured or hard to reach
References
Publications (1)
- DERIVEDSoler M, Alfaro K, Masch RJ, Conzuelo Rodriguez G, Qu X, Wu S, Sun J, Hernandez Jovel DM, Bonilla J, Puentes LO, Murillo R, Alonzo TA, Felix JC, Castle P, Cremer M. Safety and Acceptability of Three Ablation Treatments for High-Grade Cervical Precancer: Early Data From a Randomized Noninferiority Clinical Trial. JCO Glob Oncol. 2022 Dec;8:e2200112. doi: 10.1200/GO.22.00112. PMID 36525620