NCT05078528

Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,060 (estimated)
• Sponsor: Barretos Cancer Hospital · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-09-20
• Primary completion: 2025-08-03
• Completion: 2025-12-03
• First posted: 2021-10-14
• Last updated: 2025-02-06

Locations

2 sites across 1 country: Brazil