Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02367625 |
| Other study ID # |
1UH2CA189923-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2016 |
| Est. completion date |
October 2019 |
Study information
| Verified date |
April 2021 |
| Source |
Jhpiego |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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,
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.
Description:
The World Health Organization (WHO) recently released the WHO guidelines for screening and
treatment of precancerous lesions for cervical cancer prevention23 which recommends a
screenand- treat approach for cervical cancer prevention (CECAP), with cryotherapy being the
first choice of treatment for women who have a positive screen. Cryotherapy using nitrous
oxide (N2O) or carbon dioxide (CO2) to induce cryonecrosis of dysplastic tissues followed by
regeneration of normal cervical epithelium is the most common intervention used in LMICs
because it is simple and safe enough for mid-level providers such as nurses or midwives to
operate, and can be performed without anesthesia or electricity.
CO2 is more often used than N2O due to its wider availability and lower cost. Mid-level
providers have been trained successfully to perform cryotherapy safely and with a high degree
of acceptability.24,25,26 Adverse effects after cryotherapy are relatively uncommon and
generally minor, reported in 1-2% of women. A recent meta-analysis of the effectiveness of
cryotherapy found cure rates of 85% and 92%, respectively, in CIN 2 and CIN 3. An alternative
to cryotherapy, loop electrosurgical excisional procedure (LEEP) has largely supplanted
cryotherapy in well-resourced settings, as it provides a surgical specimen for pathologic
assessment and can be used on large lesions ineligible for cryotherapy. However, LEEP
requires electricity, is more costly, requires a higher level of training and is associated
with a higher rate of complications, all of which complicate its routine use in LMICs. While
LEEP may be available in national referral centers, WHO recommends cryotherapy in settings
where it is not available. Cost, reliability, durability and reparability are all factors
that prohibit the scale-up necessary for current cryotherapy methods to match the volume of
population-based screening needed to achieve a marked decrease in cervical cancer morbidity
and mortality. Each cryotherapy unit costs approximately $2,000, resulting in approximately
80% of the treatment cost of cryotherapy being directly attributed to equipment cost.
Additionally, the design involves many custom parts available only through the manufacturers,
which are all based in the U.S. or Europe. This prohibits local repairs and limits the life
of the product to only one or two years (or even less when spare parts are not available).
Cryoguns were initially developed for use with N2O but they can be used with CO2. CO2 is
approximately one fifth of the cost of N2O; however CO2, in its various usage, from
recreational to medical grade, is less regulated and often of variable purity and
concentration-leading to more equipment failures. Last but not least, the design of the
equipment makes it inefficient with the use of CO2 gas, increasing cost and missed
opportunities while the gas cylinder is being refilled at a central gas supply depot. In most
LMICs, this means sending the gas cylinder to the capital city. On average, a single 50lb CO2
tank can treat only 10 to 15 women. The subject of this proposal, CryoPop, is a new
technology specifically designed for LMIC settings and more appropriate to support
see-and-treat efforts because of its low cost and durability. The CryoPop device is currently
expected to cost one tenth of the price of current devices while also using one tenth of the
CO2 supply, thereby substantially reducing purchase price coupled with far greater efficiency
in the use of CO2, making the CryoPop attractive for further investment. Moreover, this
device is designed to have minimum moving components which at the same time are inexpensive
to replace and easy to repair in-situ by the providers themselves. Finally, the CryoPop is
not tethered to the gas canister during the procedure, adding more safely to the process by
not having to be concerned over tank or gas line placement. The goal is to have a device for
the frontline where screening is happening and provide the unique opportunity of minimizing
if not preventing loss to follow-up of screen-positive women.
This will accelerate access to cervical cancer prevention and treatment services by enabling
implementation of SVA to rural, underdeveloped regions, most of which have never had CECAP
programs.
