Pocket Colposcopy Using CARE Algorithm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorDuke University
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Pocket Colposcope
DeviceEach patient will receive treatment in order to prevent cervical cancer
Treatment groups
1,079 Participants
are divided into 1 treatment groupGroup A: Pocket Assisted ColposcopyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of the Pocket CARE in detecting pre-cancer
Sensitivity will be reported as a percentage
Time frame
Day of imaging (Day 1)2
Specificity of the Pocket CARE in detecting pre-cancer
Specificity will be reported as a percentage
Time frame
Day of imaging (Day 1)3
Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer
PPV will be reported as a percentage
Time frame
Day of imaging (Day 1)4
Negative Predictive Value (NPV) of the Pocket CARE in detecting pre-cancer
NPV will be reported as a percentage
Time frame
Day of imaging (Day 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
Kenya Medical Research Institute
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov