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Recruiting

NCT Number: NCT06458062

Pocket Colposcopy Using CARE Algorithm

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.

Recruiting

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Key information

Conditions

Cervical Cancer Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute

Nairobi, Kenya

Location status: Recruiting

Location contact

Francesca Odhiambo, MBcHB, MMed

CONTACT

[email protected]

0799427912

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pocket Colposcope

Device

Each patient will receive treatment in order to prevent cervical cancer

Primary outcomes

  1. Sensitivity of the Pocket CARE in detecting pre-cancer

    Time frame: Day of imaging (Day 1)

    Sensitivity will be reported as a percentage

  2. Specificity of the Pocket CARE in detecting pre-cancer

    Time frame: Day of imaging (Day 1)

    Specificity will be reported as a percentage

  3. Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer

    Time frame: Day of imaging (Day 1)

    PPV will be reported as a percentage

  4. Negative Predictive Value (NPV) of the Pocket CARE in detecting pre-cancer

    Time frame: Day of imaging (Day 1)

    NPV will be reported as a percentage

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Huchko, MD

CONTACT

[email protected]

919-684-8111

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Kenya Medical Research Institute
  • National Cancer Institute (NCI)

Registry information

Official study title

Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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