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Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine

NCT05340322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2024-07-23

Study results available
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Summary

The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. The objective is to provide colposcopy capability to rural communities in Peru potentially using Telehealth. Approximately 10,000 women will receive self HPV test kit for community health workers. Of these participants, approximately 1,000 HPV+ participants will be invited to participate in this pocket colposcopy study. Approximately 500 of these participants may require treatment using thermocoagulation.

Conditions

Interventions

DEVICE

Colposcopy using pocket colpscope and thermocoagulator

If HPV+, visualization with pocket colposcope and treatment with thermocoagulator

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Universidad Peruana Cayetano Heredia

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Nimmi Ramanujam, Ph.D. · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-04-15
Completion
2023-10-15
FDA Device
Yes

Countries

  • Peru

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 NCT05340322 on ClinicalTrials.gov