N/A
N=503
Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine
Cervical Cancer · HPV Infection · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT05340322 ↗Enrolled (actual)
503
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of HPV Positive Women Examined — 503 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Colposcopy using pocket colpscope and thermocoagulator (Device)
- Age
- Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of HPV Positive Women Examined |
503 | — |
| SECONDARY Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment |
488 | — |
Summary
The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. The objective is to provide colposcopy capability to rural communities in Peru potentially using Telehealth. Approximately 10,000 women will receive self HPV test kit for community health workers. Of these participants, approximately 1,000 HPV+ participants will be invited to participate in this pocket colposcopy study. Approximately 500 of these participants may require treatment using thermocoagulation.
Eligibility Criteria
Inclusion Criteria
- HPV+ pap smear
- Women must between the ages of 30-49yo
Exclusion Criteria
- HPV (-) pap smear
- people without a cervix
Data sourced from ClinicalTrials.gov (NCT05340322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.