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Pocket Colposcopy Using CARE Algorithm

Not Applicable
Recruiting
Conditions
HPV Infection
Cervical Cancer
Registration Number
NCT06458062
Lead Sponsor
Duke University
Brief 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.

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 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
1054
Inclusion Criteria
  1. Age > 25 years old and < 65 years old
  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
  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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Sensitivity of the Pocket CARE in detecting pre-cancerDay of imaging (Day 1)

Sensitivity will be reported as a percentage

Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancerDay of imaging (Day 1)

PPV will be reported as a percentage

Specificity of the Pocket CARE in detecting pre-cancerDay of imaging (Day 1)

Specificity will be reported as a percentage

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kenya Medical Research Institute

🇰🇪

Nairobi, Kenya

Kenya Medical Research Institute
🇰🇪Nairobi, Kenya
Francesca Odhiambo, MBcHB, MMed
Contact
0799427912
fodhiambo@kemri-rctp.org

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