Health Condition 1: 1- Obstetrics
Conditions
Interventions
Intervention1: CryoPop Device: 1. New device designed specifically for LMIC settings and is appropriate for see and treat approach
2. Advantages include Low cost , Portability, Reparability ,Durabilit
Sponsors
National Institute of Health and National Cancer Institute USA
Eligibility
Inclusion criteria
Inclusion criteria: 1. High-grade squamous intraepithelial lesion of the cervix (CIN 2/3), confirmed on histology 2. Eligible for cryotherapy based on size of lesion (occupies 3. Willing and able to provide consent
Exclusion criteria
Exclusion criteria: 1. Menopausal 2. History of hysterectomy 3. Known HIV+ or active cervical infections 4. Lesion occupies >75% of cervix and/or extends into the endo cervical canal 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is proportion of women with normal Pap smear at 6 months post treatment. Sample size is calculated with the goal of having at least 80% statistical power to detect non-inferiority of the CryoPop protocols compared to the historical efficacy of the standard device for the primary outcome at 0.05 one-sided level of statistical significanceTimepoint: 6 weeks, 3 months and 6 Months after Cryotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes relate to safety and it is anticipated that incidence of adverse outcomes will be 1- 2% or less, and that most will be minorTimepoint: 6 weeks after cryotherapy | — |
Countries
India
Contacts
Public ContactDr Anita Dalal
J N Medical College,
Outcome results
None listed