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Low-cost Imaging Technology for Global Prevention of Cervical Cancer

RecruitingNAAges 25 Years - anyFemaleBarretos Cancer Hospital
NCT05078528 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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;
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What it tests

  • Multimodal Mobile Colposcope (MMC)
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Where

2 sites
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Barretos Cancer Hospital
Barretos, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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