CompletedNot Applicable

1:1 Comparison of the Pocket Colposcope in Kenya

Kenya434 participantsStarted 2022-11-28

Plain-language 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. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope

Who can participate

Age range25 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Age \> 25 years old and \< 65 years old
✓. Sex: Female
✓. Positive HPV test within past 6 months
✓. HIV+ women

Exclusion criteria

✕. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
✕. Women with a negative HPV test
✕. Patients incapable of giving informed consent
✕. Women with a history of cervical cancer
✕. Pelvic exam concerning for cervical cancer or cervical infection

What they're measuring

Percent of Exams With Lesions Identified

Timeframe: Baseline

Sensitivity

Timeframe: Baseline

Specificity

Timeframe: Baseline

Negative Predictive Value (NPV)

Timeframe: Baseline

Positive Predictive Value (PPV)

Timeframe: Baseline

Trial details

NCT IDNCT04998318

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-16

Results submitted2025-05-16

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