Pocket Colposcopy Using CARE Algorithm

Last updated: May 6, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Pelvic Cancer

Vaginal Cancer

Treatment

Pocket Colposcope

Clinical Study ID

NCT06458062
Pro00106169_1
1U01CA269192
  • Ages 25-65
  • Female

Study Summary

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 4-6 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 25 years old and < 65 years old

  2. Sex: Female

  3. Positive HPV test within past 6 months

Exclusion

Exclusion Criteria:

  1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unlessabsolutely indicated)

  2. Women with a negative HPV test

  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

Study Design

Total Participants: 1054
Treatment Group(s): 1
Primary Treatment: Pocket Colposcope
Phase:
Study Start date:
February 15, 2024
Estimated Completion Date:
April 30, 2027

Study 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 reflects Phase 1 of Aim 3 of the grant. Phase 2 of Aim 3 will be added once approved. Phase 1 of Aim 3 was previously included within NCT04998318.

Connect with a study center

  • Kenya Medical Research Institute

    Nairobi,
    Kenya

    Active - Recruiting

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