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

Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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.
    

Study Type

Interventional

Primary Outcome

The primary variable of interest is the width of necrosis on the cervical pathologic specimen

Condition

Cervical Dysplasia

Intervention

CryoPop

Study Arms / Comparison Groups

 Arm 1

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

40

Start Date

February 2016

Completion Date

October 2019

Primary Completion Date

May 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Must be 30-49 years old

          2. Must have normal cervical cytology

          3. Must have planned total hysterectomy for other gynecological indication

        Exclusion Criteria:

          1. Menopause

          2. Past history of cervical dysplasia

          3. Known HIV+or history of other sexually transmitted infections -
      

Gender

Female

Ages

30 Years - 49 Years

Accepts Healthy Volunteers

No

Contacts

Jean Anderson, MD, , 

Location Countries

Philippines

Location Countries

Philippines

NCT ID

NCT02367625

Organization ID

1UH2CA189923-01

Responsible Party

Sponsor

Study Sponsor

Jhpiego

Collaborators

 University of the Philippines

Study Sponsor

Jean Anderson, MD, Study Director, Jhpiego

Verification Date

April 2021