RECRUITINGINTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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
Who Should NOT Join This Trial:
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 willing to sign a consent form
4. Women with a history of cervical cancer
5. Pelvic exam concerning for cervical cancer or cervical infection
6. History of hysterectomy
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Pocket Colposcope
Each patient will receive treatment in order to prevent cervical cancer
Locations (1)
Kenya Medical Research Institute
Nairobi, Kenya