Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Barretos Cancer Hospital

Status: Enrolling

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Device: Multimodal Mobile Colposcope (MMC)

Study type: Interventional

Funder types: Other

Identifiers

NCT05078528

38969820.9.1001.5437

Details and patient eligibility

About

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.

Enrollment: 1,060 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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;

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,060 participants in 1 patient group

Experimental group - MMC

Experimental group

Description:

Imaging of study participants will be performed during the colposcopy examination. The mobile colposcope and the confocal imaging probe, together referred to as the Multimodal Mobile Colposcope (MMC), will be used to image and/or record videos the cervix. Cervical biopsies will be performed using biopsy forceps per standard protocols.

Treatment:

Device: Multimodal Mobile Colposcope (MMC)