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

Plain Language Summary

Simplified for easier understanding

This study is testing a low-cost imaging device to detect cervical pre-cancer and cancer during colposcopy, with the goal of making cervical cancer prevention accessible in low-resource settings around the world. **You may be eligible if...** - You are a woman over 25 years old - You are already scheduled for a colposcopy due to an abnormal cervical screening result or a history of cervical dysplasia - You have a negative pregnancy test (or are not pregnant) **You may NOT be eligible if...** - You are under 25 years old - You have had a hysterectomy (removal of the cervix) - You have a known allergy to proflavine or acriflavine (dyes used in the procedure) - You are pregnant or nursing - You are unable or unwilling to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.