Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Last updated: February 4, 2025
Sponsor: Barretos Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Cervical Intraepithelial Neoplasia

Treatment

Multimodal Mobile Colposcope (MMC)

Clinical Study ID

NCT05078528
38969820.9.1001.5437
  • Ages > 25
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Women >25 years of age;

  • Women undergoing colposcopy due to abnormal cervical screening or follow-up for ahistory 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 signingspecific Informed Consent Document.

Exclusion

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 giveconsent;

Study Design

Total Participants: 1060
Treatment Group(s): 1
Primary Treatment: Multimodal Mobile Colposcope (MMC)
Phase:
Study Start date:
September 20, 2021
Estimated Completion Date:
December 03, 2025

Connect with a study center

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul 90020-090
    Brazil

    Active - Recruiting

  • Barretos Cancer Hospital

    Barretos, São Paulo 14784-400
    Brazil

    Active - Recruiting

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