| NCT ID | NCT06458062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,079 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,079 participants in total. It began in 2024-02-15 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Megan Huchko, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06458062 clinical trial?
This trial is open to female participants only, aged 25 Years or older, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06458062 currently recruiting?
Yes, NCT06458062 is actively recruiting participants. Contact the research team at megan.huchko@duke.edu for enrollment information.
Where is the NCT06458062 trial being conducted?
This trial is being conducted at Nairobi, Kenya.
Who is sponsoring the NCT06458062 clinical trial?
NCT06458062 is sponsored by Duke University. The principal investigator is Megan Huchko, MD at Duke University. The trial plans to enroll 1,079 participants.
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