Trial results for a study comparing the Pocket Colposcope to standard of care for cervical lesion detection in women, including those with HIV, were posted on ClinicalTrials.gov on 2025-06-24. The Pocket Colposcope identified lesions in 14.3% of exams in its primary group.
Background
Cervical cancer remains a significant health concern, particularly in regions with limited access to advanced screening technologies. Human Papillomavirus (HPV) infection is the primary cause of cervical cancer, and women living with HIV are at an increased risk of both HPV infection and progression to cervical lesions. Effective screening methods are crucial for early detection and treatment, especially in settings where resources for traditional colposcopy may be scarce. The Pocket Colposcope, with FDA 510k clearance, aims to provide an accessible screening tool for cervical cancer screening.
Trial design
This completed study, designated as Phase NA, enrolled 434 participants to compare the Pocket Colposcope with standard-of-care visual inspection for cervical lesion detection. The study focused on women who were HPV-positive and planned to undergo treatment at six Ministry of Health-supported outpatient clinics in Kisumu County, Kenya. Participants were randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope. The conditions investigated included Cervical Cancer, HPV Infection, and HIV Infections.
Key results
The trial reported several key measurements comparing the Pocket Colposcope to standard of care:
- Percent of Exams With Lesions Identified:
- For the Pocket Colposcope group, this was 14.3 percent of exams.
- For the Standard of Care (VIA) group, this was 17.3 percent of exams.
- In a mis-weighted randomization to the Pocket Colposcope group, this was 0 percent of exams.
- In a mis-weighted randomization to the Standard of Care (VIA) group, this was 21.1 percent of exams.
- Sensitivity:
- The Pocket Colposcope demonstrated a sensitivity of 26.3 percent.
- Standard of Care (VIA) demonstrated a sensitivity of 25.0 percent.
- Specificity:
- The Pocket Colposcope demonstrated a specificity of 88.9 percent.
- Standard of Care (VIA) demonstrated a specificity of 84.0 percent.
- Negative Predictive Value (NPV):
- For the Pocket Colposcope, the NPV was 82.9 percentage.
- For Standard of Care (VIA), the NPV was 87.1 percentage.
- Positive Predictive Value (PPV):
- For the Pocket Colposcope, the PPV was 37.5 percentage.
- For Standard of Care (VIA), the PPV was 20.6 percentage.
What this means
The results provide comparative data on the performance of the Pocket Colposcope against standard-of-care visual inspection for detecting cervical lesions in HPV-positive women, including those with HIV. The Pocket Colposcope showed a sensitivity of 26.3% and a specificity of 88.9%, compared to 25.0% sensitivity and 84.0% specificity for standard of care. While the Pocket Colposcope had a higher positive predictive value (37.5% vs 20.6%), its negative predictive value was slightly lower (82.9% vs 87.1%). These findings contribute to understanding the diagnostic utility of the device in a real-world setting.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04998318, titled "1:1 Comparison of the Pocket Colposcope in Kenya", were posted on 2025-06-24 on clinicaltrials.gov.