Low-cost Imaging Technology for Global Prevention of Cervical Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2025-12-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multispectral Digital Colposcope With Probe for Detection of Cervical Intraepithelial Neoplasia

NCT02406352

Carcinoma in Situ of Uterine Cervix Cervical Intraepithelial Neoplasias High Grade Cervical Intraepithelial Neoplasia

UNKNOWN NA

Combined Digital Colposcopy Analysis to Improve Cervical Precancer and Cancer Detection

NCT01094132

Cervical Cancer Precancerous Condition

COMPLETED PHASE2

Third-Generation Nanopore HPV Integration Site for Precise Prediction of Cervical Cancer Prognosis

NCT06644677

Cervical Cancers HPV Testing Nanopore Sequencing +2 more

COMPLETED

A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings

NCT06810427

Cervical Intraepithelial Neoplasia

ACTIVE_NOT_RECRUITING NA

HRME: Screening for Cervical Cancer and Its Precursors in Low-Resource Settings

NCT02494310

Neoplasia of the Uterine Cervix Cancer Prevention Cervical Intraepithelial Neoplasia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Intraepithelial Neoplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Multimodal Mobile Colposcope (MMC)

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No