An Innovative Treatment for Cervical Precancer (UH3)

Summary

The purpose of this academic-industrial partnership will compare the CryoPen® and thermoablator to traditional CO2-based cryotherapy for the treatment of cervical precancer in low and middle income countries (LMICs) and investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

DEVICE

CO2 standard therapy

Standard therapy using carbon dioxide for freezing of tissue

DEVICE

CryoPen

Provides a means of freezing tissue without the use of gases or liquids

DEVICE

Thermocoagulator

Thermoablation

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Basic Health International

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Instituto Salvadoreno del Seguro Social

  collaborator UNKNOWN

• Hospital Universitario San Ignacio

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Shanxi Bethune Hospital

  collaborator OTHER

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• Miriam Cremer, MD · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2024-08-15

Completion

2024-08-15

Countries

• China
• Colombia
• El Salvador

Study Locations