RecruitingNot ApplicableNCT05078528

Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer

Sponsor

Barretos Cancer Hospital

Enrollment

1,060 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

Cervical Intraepithelial Neoplasia

Summary

Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.

Eligibility

Sex: FEMALEMin Age: 25 Years

Inclusion Criteria4

Women \>25 years of age;
Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;
Women of childbearing potential must have a negative urine or blood pregnancy test;
Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.

Exclusion Criteria5

Women under 25 years of age;
Women who have undergone hysterectomy with removal of the cervix;
Women with known allergy to proflavine or acriflavine;
Women who are pregnant or nursing at the time of enrollment;
Incapacitated women or in vulnerable situations or who are not willing to give consent;

Interventions

DEVICEMultimodal Mobile Colposcope (MMC)

Women referred for colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.