Pocket Colposcopy Using CARE Algorithm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pocket Colposcope.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, HPV Infection. Basic parameters: from 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
Overview
The Pocket colposcope has 510k FDA clearance and has been successfully used in \~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at four Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.
Detailed description
Women undergo Pocket-Assisted VIA (PA-VIA) and green light imaging using the Pocket Colposcope. Women will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure. Once we have obtained enough images to develop the CARE algorithm, it will also be used to assist the provider in diagnosis.
This record previously reflected only Phase 1 of Aim 3 of the grant. Phase 1 of Aim 3 was originally included within NCT04998318. The details for Phase 2 of Aim 3 were added to this record in September 2025 after approval.
Interventions
- Device Pocket Colposcope
Each patient will receive treatment in order to prevent cervical cancer
Primary outcome measures
- Sensitivity of the Pocket CARE in detecting pre-cancer [Time frame: Day of imaging (Day 1)]
- Specificity of the Pocket CARE in detecting pre-cancer [Time frame: Day of imaging (Day 1)]
- Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer [Time frame: Day of imaging (Day 1)]
- Negative Predictive Value (NPV) of the Pocket CARE in detecting pre-cancer [Time frame: Day of imaging (Day 1)]
Eligibility criteria
Inclusion criteria
- Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH)
- Sex: Female
- Positive HPV test within past 6 months
Exclusion criteria
- Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
- Women with a negative HPV test within the past 9 months
- Patients incapable of giving informed consent
- Women with a history of cervical cancer
- Pelvic exam concerning for cervical cancer or cervical infection
- History of hysterectomy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Kenya · 1 center
- Kenya Medical Research Institute — Nairobi
Identifiers
NCT: NCT06458062 · Pro00114753 · 1U01CA269192