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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 25
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Barretos Cancer Hospital
RECRUITING
Barretos
Irmandade Santa Casa de Misericórdia de Porto Alegre
RECRUITING
Porto Alegre
Contact Information
Primary
Júlio César P Resende, MD, PhD
julio.possati@uol.com.br
+55 (17) 3321-6600
Backup
Mila P Salcedo, MD, PhD
mpsalcedo@mdanderson.org
+1-832-316-3774
Time Frame
Start Date: 2021-09-20
Estimated Completion Date: 2025-12-03
Participants
Target number of participants: 1060
Treatments
Experimental: Experimental group - MMC
Imaging of study participants will be performed during the colposcopy examination. The mobile colposcope and the confocal imaging probe, together referred to as the Multimodal Mobile Colposcope (MMC), will be used to image and/or record videos the cervix. Cervical biopsies will be performed using biopsy forceps per standard protocols.
Sponsors
Leads: Barretos Cancer Hospital
Collaborators: William Marsh Rice University, Irmandade Santa Casa de Misericórdia de Porto Alegre, M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov

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