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Low-cost Imaging Technology for Global Prevention of Cervical Cancer

NCT05078528 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1060

Last updated 2025-02-06

No results posted yet for this 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.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

DEVICE

Multimodal 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.

Sponsors & Collaborators

  • William Marsh Rice University

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    collaborator OTHER

  • Barretos Cancer Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2025-08-03
Completion
2025-12-03

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078528 on ClinicalTrials.gov