CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
CryoPopdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04154644
NCT04154644N/ACompleted

Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia

Jhpiego·interventional·Posted Nov 6, 2019·Updated Jan 14, 2022

In Brief

A clinical study evaluating CryoPop for Cervical Dysplasia. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Globally, cervical cancer is the second most common cancer for women and kills approximately 250,000 women every year, with the annual number of deaths expected to increase to 410,000 by 2030. The majority (88%) of these deaths occur in low- and middle-income countries (LMICs) where screening and prevention services are limited. Prevention of cervical cancer by identification and treatment of cervical cancer precursors is key, since treatment resources for invasive disease are scarce. A cervical cancer screening program cannot be effective unless it is linked with a proven intervention to prevent the development of cervical cancer. The World Health Organization (WHO) recently released the WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention, which recommends a screen-and-treat approach for cervical cancer prevention, with cryotherapy being the first choice of treatment for women who have a positive screen. However, these programs are still slow to be implemented in part due to the current high cost and low efficiency of cryotherapy equipment that is often prone to breaking. Jhpiego, an affiliate of Johns Hopkins University (JHU), has developed a new cryotherapy device, CryoPop, that is one tenth the cost of current equipment while also ten times more efficient. Once proven safe, feasible and effective, CryoPop could save tens of thousands of lives in low- and middle-income countries each year by preventing cervical cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 6, 2019
Enrollment StartApr 9, 2019
Primary CompletionOct 31, 2021
Study CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.7 years ago

Interventions

CryoPopdevice

The new CryoPop device will be tested on women with abnormal cytology. Benchmark testing occurred in the previous study and CryoPop was found to be non-inferior to standard cryotherapy device (MedGyn) in woman with normal cytology.