CLEVELAND CLINIC FOUNDATION:

Development of Alternative Ablation Device for

Cervical Pre-Cancer Treatment

Year of Grant: 2017

Location: United States

 

Most cases of cervical cancer are due to infections of the human papillomavirus (HPV) which can be detected and treated before developing into invasive disease.

 

Screening technologies have advanced significantly, but innovation in treatment methods has lagged behind. The standard treatment in

low-income settings consists of gas-based cryotherapy, the use of cryogenic gas to freeze pre-cancerous lesions. However, the required gas tanks are costly to refill, difficult to transport and pose the danger of explosion.

 

There is an urgent need for low-cost, easy-to-use, portable treatment options that can reduce the cervical cancer burden in high-need areas. To address this gap, the team is conducting a clinical trial to test the LMIC-adapted CryoPen®, a new cryotherapy device customized for use in these settings.

 

While the Cryopen® does not require cryogenic gas and runs on electricity or even a car battery, some difficulties remain:

1)              The device weighs about 20 lb, limiting its portability

2)              It needs two hours to cool before it can be used

3)              There is a 15-minute wait time between patients

4)              It requires a consumable good (ethanol) for proper use

 

 

Because of these limitations, the team has looked into the feasibility of thermoablation, an alternative treatment that utilizes heat to destroy

pre-cancerous lesions. While this method has been in use since the 1970s, there are no clinical trials evaluating its efficacy or safety.

 

Despite the lack of data, several cervical cancer screening programs have adopted the use of this technology because it is simple to use. The purpose of this proposal is to add an arm with 384 patients to the current NCI funded randomized control trial comparing gas-based cryotherapy with non gas based cryotherapy(CryoPen) for the treatment of CIN2+. This new arm

will compare the efficacy of thermoablation with the aforementioned approaches and will take place at 3 hospitals located in El Salvador, Colombia and Peru.

 

This four year study will enable the team to adequately assess thermoablation as another innovative treatment option. The study team has collaborated with the manufacturer of a widely-marketed thermoablator to design a light, handheld prototype that can operate on an external battery.

If successful, thermoablation has the potential to reach thousands of women in the most vulnerable areas in the coming years.

 

Through this trial, the team plans to gather urgently-needed evidence that will serve to incorporate novel treatments into the international recommendations that guide cervical pre-cancer treatment globally.

The development of a safe and effective pre-cancer treatment that can be deployed in low-resource settings has the potential to eradicate cervical cancer and ensure that no woman dies from this completely preventable disease.