Developing a low-cost imaging device to prevent cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create and validate a low-cost Multimodal Mobile Colposcope (MMC) designed for cervical cancer prevention in low-resource settings. The MMC combines the imaging capabilities of a mobile colposcope with those of a fiber-optic confocal imaging probe to enhance diagnostic accuracy. By addressing the lack of clinical expertise and infrastructure in these regions, the study seeks to improve screening and diagnosis of cervical intraepithelial neoplasia. The intervention targets women over 25 who are undergoing colposcopy due to abnormal cervical screening results.

Why it matters

Who can join: the full rules

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;

Where it's running

• Irmandade Santa Casa de Misericórdia de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Barretos Cancer Hospital
  Barretos, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Júlio César P Resende, MD, PhD
• Email: julio.possati@uol.com.br
• Phone: +55 (17) 3321-6600

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.