Clinical trial · Interventional
Pocket Colposcopy Using CARE Algorithm
Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pocket Colposcope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pocket Assisted Colposcopy
- description
- Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. Images will be acquired. A biopsy will be obtained using the pocket. Random biopsies will be obtained from 2 quadrants in the absence of a visible lesion.
- interventionNames
- Device: Pocket Colposcope
Primary outcomes (4)
- measure
- Sensitivity of the Pocket CARE in detecting pre-cancer
- timeFrame
- Day of imaging (Day 1)
- description
- Sensitivity will be reported as a percentage
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH) 2. Sex: Female 3. Positive HPV test within past 6 months Exclusion Criteria: 1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated) 2. Women with a negative HPV test within the past 9 months 3. Patients incapable of giving informed consent 4. Women with a history of cervical cancer 5. Pelvic exam concerning for cervical cancer or cervical infection 6. History of hysterectomy
References
Publications (0)
Data not yet available