N/A
N=1,132
An Innovative Treatment for Cervical Precancer (UH3)
Cervical Intraepithelial Neoplasia
Bottom Line
View on ClinicalTrials.gov: NCT03084081 ↗Enrolled (actual)
1,132
Serious AEs
0.1%
Results posted
Apr 2025
Primary outcome: Primary: Proportion of Participants With Residual CIN2+ — 18; 29; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CO2 standard therapy (Device); CryoPen (Device); Thermocoagulator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Cleveland Clinic
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Residual CIN2+ |
18; 29; 25 | — |
| SECONDARY Self-reported Pain |
2; 2; 4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03084081). 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.