RecruitingNot Applicable

Pocket Colposcopy Using CARE Algorithm

Kenya1,079 participantsStarted 2024-02-15

Plain-language 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 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.

Who can participate

Age range25 Years

SexFEMALE

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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

What they're measuring

Sensitivity of the Pocket CARE in detecting pre-cancer

Timeframe: Day of imaging (Day 1)

Specificity of the Pocket CARE in detecting pre-cancer

Timeframe: Day of imaging (Day 1)

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

Timeframe: Day of imaging (Day 1)

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

Timeframe: Day of imaging (Day 1)

Trial details

NCT IDNCT06458062

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Megan Huchko, MD

919-684-8111 megan.huchko@duke.edu

View on ClinicalTrials.gov More Cervical Cancer trials