Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

100 women with abnormal cervical cytology will receive cryotherapy with the experimental CryoPop device

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.

CryoPop

Jean Anderson, MD

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.

The World Health Organization (WHO) Guidelines for screening and treatment of precancerous lesions for cervical cancer prevention 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. 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 competently-trained mid-level providers such as nurses and midwives to operate, and can be performed without anesthesia or electricity. Adverse effects after cryotherapy are relatively uncommon and generally minor, reported in 1-2% of women. A recent meta-analysis of 77 studies (with moderate to high quality evidence) regarding the effectiveness of cryotherapy found cure rates of 92% and 85%, respectively, in CIN 2 and CIN 3. Cure was defined as normal cytology or disease-free state (generally with colposcopy +/- biopsy) at the follow-up visit, implying absence of persistent disease or recurrent lesions after treatment and length of follow-up varied from 3 months to 10 years. A more recent systematic review and meta-analyses of benefits and harms of cryotherapy, as well as Loop Electrosurgical Excision Procedure (LEEP) and cervical conization (167 studies) found a residual/ recurrence rate of cervical dysplasia (CIN 2-3) of 5% at 12 months' follow-up. Major and minor adverse events occurred in less than 1% of women and were fewer with cryotherapy than with the other approaches. Limited data suggests that preterm delivery in subsequent pregnancy may be increased (\<2%) with cryotherapy or LEEP.

Cost, reliability, durability, portability 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-$7500, resulting in approximately 80% or more of the treatment cost of cryotherapy being directly attributed to equipment cost. The design involves many custom parts available only through the manufacturers, which are all based in the US 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). Additionally, the current technology requires huge amount of N20 or CO2 requiring large gas cylinders which are heavy and costly-the cost to refill a CO2 tank can be up to $200.

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, portability, reparability and durability. The CryoPop device is currently expected to cost one half of the price of current devices while also using one tenth of the CO2 supply, thereby substantially reducing the recurring cost of refilling a smaller and more portable gas supply with far greater efficiency in the use of CO2. Moreover, this device is designed to have minimal 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 safety to the treatment procedure 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 single-visit approach (SVA) to rural, underdeveloped regions, most of which have never had cervical cancer prevention (CECAP) programs.

This clinical trial is Part 2 of a 2-part research study. Part 1 of this research study is registered under:

1UH2CA189923-01 Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia NCT02367625

Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia [Part II]

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

Data and research materials will be made available for public access upon the completion of the data collection. This data will be shared through the JHU Data Archive, which uses an established repository platform (Dataverse) and is supported by preservation practices, with administrative help for preparing deposits provided by Johns Hopkins Data Services. Deposited data is given standard data citations and persistent identifiers (DOIs) and will be archived for a minimum of 5 years, with the possibility of renewal.

The proportion of pap smears and colposcopy/biopsies that are negative (have no dysplasia or cancer) as confirmed by Pap smear and/or biopsy read by 2 or 3 pathologists. If there is discordance between the Pap and biopsy readings, the reading with the greater abnormality will have priority as an endpoint.

Percent of adverse events (AE) and serious adverse events (SAE) will be reported for the study sample. These values will be compared to the safety profile reported for another standard commercially available cryotherapy device.

Jawaharlal Nehru Medical College

Jhpiego

20 women with normal cervical cytology will be randomized to receive MedGYn MGC 200 therapy

The new CryoPop device will be compared to standard cryotherapy

MedGyn MGC 200

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia [Part II]	NCT04154644	Cervical Dyspla...	CryoPop	30 Years - 49 Years	Jhpiego
Performance, Safety, and Efficacy of a New Cyrotherapy Device for Cervical Dysplasia	NCT02367625	Cervical Dyspla...	CryoPop MedGyn MGC 200	30 Years - 49 Years	Jhpiego
Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia [Part II]	NCT04154644	Cervical Dyspla...	CryoPop	30 Years - 49 Years	Jhpiego
Performance, Safety, and Efficacy of a New Cyrotherapy Device for Cervical Dysplasia	NCT02367625	Cervical Dyspla...	CryoPop MedGyn MGC 200	30 Years - 49 Years	Jhpiego

Spots Global Cancer Trial Database for cryopop

Every month we try and update this database with for cryopop cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cryopop

Every month we try and update this database with for cryopop cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cryopop cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.