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Pocket Colposcopy Using CARE Algorithm

NCT06458062 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1079

Last updated 2026-01-12

No results posted yet for this study

Summary

The Pocket colposcope has 510k FDA clearance and has been successfully used in \~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at four Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.

Conditions

Interventions

DEVICE

Pocket Colposcope

Each patient will receive treatment in order to prevent cervical cancer

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Megan Huchko, MD · Duke University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

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 NCT06458062 on ClinicalTrials.gov