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

NCT02367625 | Completed

• 1 other identifier: 1UH2CA189923-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dysplasia

Outcome Measures

Primary Outcomes (1)

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

  two years

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Device: CryoPop

Arm 2

ACTIVE COMPARATOR

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

Device: MedGyn MGC 200

Interventions

CryoPop DEVICE

The new CryoPop device will be compared to standard cryotherapy

Arm 1

MedGyn MGC 200 DEVICE

Standard cryotherapy

Arm 2

Eligibility Criteria

• Age: 30 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be 30-49 years old
• Must have normal cervical cytology
• Must have planned total hysterectomy for other gynecological indication

You may not qualify if:

• Menopause
• Past history of cervical dysplasia
• Known HIV+or history of other sexually transmitted infections -

Sponsors & Collaborators

• Jhpiego: lead
• University of the Philippines: collaborator

Study Sites (1)

University of the Phillipines, College of Medicine

Manila, Philippines

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jean Anderson, MD

  Jhpiego

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2014
• First Posted: February 20, 2015
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2019
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

PH (1)