Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154644
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Jawaharlal Nehru Medical College
Information provided by (Responsible Party):
Jhpiego

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 (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.

Condition or disease Intervention/treatment Phase
Cervical Dysplasia Device: CryoPop Not Applicable

Detailed Description:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Performance, Safety, and Efficacy of a New Cryotherapy Device for Cervical Dysplasia
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cervical Cytology
100 women with abnormal cervical cytology will receive cryotherapy with the experimental CryoPop device
Device: CryoPop
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.




Primary Outcome Measures :
  1. Efficacy of CryoPop: negative Pap smear and negative biopsy (if performed) on each study participant. [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Safety of CryoPop: Incidences of adverse events documented throughout the study. [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be 30-49 years old
  2. High-grade squamous intraepithelial lesion of the cervix (CIN 2/3), confirmed on histology
  3. Eligible for cryotherapy based on size of lesion (occupies <75% of cervix) and fully visible on colposcopy or visual inspection with acetic acid (VIA)
  4. Willing and able to provide consent.

Exclusion Criteria:

  1. Menopausal
  2. History of hysterectomy
  3. Known HIV+ or active cervical infections
  4. Lesion occupies >75% of cervix and/or extends into the endo cervical canal
  5. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154644


Contacts
Layout table for location contacts
Contact: Margaret Mensa, MSN 410 537 1984 Margaret.Mensa@jhpiego.org
Contact: Jean Anderson, MD 4106142870 janders@jhmi.edu

Locations
Layout table for location information
India
JN Medical College Recruiting
Belgaum, Karnataka, India, 590010
Contact: Anita Dalal, MD    918312444195    anitamgan@gmail.com   
Sponsors and Collaborators
Jhpiego
Jawaharlal Nehru Medical College
Investigators
Layout table for investigator information
Principal Investigator: Jean Anderson, MD janders@jhmi.edu
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Jhpiego
ClinicalTrials.gov Identifier: NCT04154644    
Other Study ID Numbers: 1UH3CA189923-01 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jhpiego:
Cryotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type