NCT04998318Completed
1:1 Comparison of the Pocket Colposcope in Kenya
Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya
Source: ClinicalTrials.gov · Last updated 24 Jun 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 434 (actual)
- First submitted
- 2 Aug 2021
- Start date
- Nov 2022
- Primary completion date
- May 2024
- Lead sponsor
- Duke University
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT04998318
What you commit to
- Study type: Interventional
- Participants enrolled: 434
- From Nov 2022 to the primary completion date, May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Women with a history of cervical cancer
- Pelvic exam concerning for cervical cancer or cervical infection
Other
- 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
Who the study is looking for
- Age \> 25 years old and \< 65 years old
- Sex: Female
- Positive HPV test within past 6 months
- HIV+ women
Age in the registry: 25 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kenya Medical Research Institute Coordinator of this site? Confirm its status | Nairobi | Kenya | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.