CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 503 enrolled
Drug / intervention
Colposcopy using pocket colpscope and thermocoagulatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05340322
NCT05340322N/ACompleted

Closing the Gap Between Identification and Treatment of Cervical Abnormalities in Lima, Perú Through Integraton of Pocket Colposcopy, Telemedicine and Visual Counseling

Duke University·interventional·Posted Apr 22, 2022·Updated Jul 23, 2024

In Brief

A clinical study evaluating Colposcopy using pocket colpscope and thermocoagulator for Cervical Cancer and 2 related conditions. Completed, enrolled 503 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPeru

Timeline

N/ACompletedFinished
2023202420252026
First PostedApr 22, 2022
Enrollment StartMay 1, 2022
Primary CompletionApr 15, 2023
Study CompletionOct 15, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.2 years ago

Interventions

Colposcopy using pocket colpscope and thermocoagulatordevice

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