Cervical CancerNCT04998318
1:1 Comparison of the Pocket Colposcope in Kenya
A study testing Pocket Colposcope in people with Cervical Cancer and HPV Infection, run by Duke University at 1 site in Kenya.
Trial 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. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the… Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Cervical Cancer, HPV Infection, HIV Infections
- What is being tested?
- Pocket Colposcope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 1 siteKenya
- Study dates
- 28 Nov 2022to 16 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 25 years old and < 65 years old
- Sex: Female
- Positive HPV test within past 6 months
- HIV+ women
Who cannot join
- Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
- Women with a negative HPV test
- Patients incapable of giving informed consent
- Women with a history of cervical cancer
- Pelvic exam concerning for cervical cancer or cervical infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya
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. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope
Read the detailed description
Women randomized to the standard-of-care arm will undergo VIA followed by Visual Inspection with Lugol's Iodine (VILI). Women randomized to the Pocket Colposcope arm will undergo Pocket-Assisted VIA (PA-VIA), green light imaging, and VILI using the Pocket Colposcope. Women in both arms will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure.
- Conditions
- Cervical Cancer, HPV Infection, HIV Infections
- Being tested
- Pocket Colposcope, Standard of Care Colposcopy
- Keywords
- cervical cancer screening, Pap smear, Colposcopy, Pap smear, colposcopy
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pocket ColposcopeDevice
Both arms will receive treatment in order to prevent cervical cancer. However, the intervention using the pocket colposcope device will be used on half the enrolled subjects.
Standard of Care ColposcopyProcedure or surgery
VIA and VILI as previously described,
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Visual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection.
Visual Inspection with Lugol's Iodine (VILI): After imaging with Acetic acid, Lugol's iodine will be applied using a fox swab noting any yellow or non-staining areas. Lesion location(s) will be noted on a clock-face diagram and used to direct biopsy if a lesion is present or random biopsies will be obtained from two quadrants in the absence of a visible lesion. Receives: Procedure: Standard of Care Colposcopy |
| Pocket Colposcope | Experimental | Pocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes.
Pocket-Assisted Visual Inspection with Lugol's Iodine (PA-VILI): After imaging with AA, Lugol's iodine will be applied using a fox swab noting any yellow or non-staining areas. Images will be acquired. A biopsy will be obtained using the pocket. Random biopsies will be obtained from 2 quadrants in the absence of a visible lesion. Receives: Device: Pocket Colposcope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Exams With Lesions Identified
The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.
Measured: Baseline
Sensitivity
Sensitivity of Pocket vs VIA
Measured: Baseline
Specificity
Specificity of Pocket vs VIA
Measured: Baseline
Negative Predictive Value (NPV)
Negative predictive value (NPV) of Pocket vs VIA
Measured: Baseline
Positive Predictive Value (PPV)
Positive predictive value (PPV) of Pocket vs VIA
Measured: Baseline
Secondary outcomes (5)
Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire
Participants were asked how much they knew about cervical cancer and cervical cancer prevention prior to the exam and after the visit.
Measured: baseline
Percent of Providers Who Reported Experiencing no Challenges During the Exam
Providers perspective was assessed using the question: 'Did you run into any of the following challenges during today's exam?'.
Measured: baseline
Percent of Participants Who Reported Experiencing Pain During Their Exam
Participant perspective of the exam was assessed by asking "Did you experience any pain throughout your exam?"
Measured: Baseline
Percent of Participants Who Expressed Confidence in Their Provider's Assessment
Participant perspective of the exam was assessed by asking "How confident are you in the provider's assessment from today's visit?"
Measured: Baseline
Percent of Participants Who Would Recommend the Exam to a Friend
Participant perspective of the exam was assessed by asking "How likely would you recommend this medical exam to a friend?"
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start28 Nov 2022
- Primary completion16 May 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Megan Huchko, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998318
- Sponsor's protocol ID
- Pro00106169
- Status last verified
- Jun 2025
- First submitted
- 2 Aug 2021
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya
- ClinicalTrials.gov ID
- NCT04998318
- Acronym / sponsor ID
- Pro00106169
- Conditions
- Cervical Cancer, HPV Infection, HIV Infections
- Keywords
- cervical cancer screening, Pap smear, Colposcopy, Pap smear, colposcopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope
Detailed description
Women randomized to the standard-of-care arm will undergo VIA followed by Visual Inspection with Lugol's Iodine (VILI). Women randomized to the Pocket Colposcope arm will undergo Pocket-Assisted VIA (PA-VIA), green light imaging, and VILI using the Pocket Colposcope. Women in both arms will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Standard of Care ColposcopyVisual Inspection with Acetic Acid (VIA): First, the cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied to the cervix using a spray bottle or fox swab. After approximately 1-minute, any changes to the cervix using the naked eye will be noted. Acetic acid may be reapplied if acetowhitening diminishes during visual inspection. Visual Inspection with Lugol's Iodine (VILI): After imaging with Acetic acid, Lugol's iodine will be applied using a fox swab noting any yellow or non-staining areas. Lesion location(s) will be noted on a clock-face diagram and used to direct biopsy if a lesion is present or random biopsies will be obtained from two quadrants in the absence of a visible lesion. |
| Pocket Colposcope | Experimental | Device: Pocket ColposcopePocket-Assisted Visual Inspection with Acetic Acid (PA-VIA): The cervix should be wiped with a cotton swab to remove any preexisting mucous and/or blood. A 3-5% acetic acid solution will be applied using a spray bottle or fox swab. After approximately 1-minute, using the Pocket Colposcope any changes to the cervix will be noted. Using the Calla Health image acquisition software, both white and green images of the cervix will be captured at low-resolution. High-resolution green light images will be obtained at the provider's discretion. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. Pocket-Assisted Visual Inspection with Lugol's Iodine (PA-VILI): After imaging with AA, Lugol's iodine will be applied using a fox swab noting any yellow or non-staining areas. Images will be acquired. A biopsy will be obtained using the pocket. Random biopsies will be obtained from 2 quadrants in the absence of a visible lesion. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 25 years old and < 65 years old
- Sex: Female
- Positive HPV test within past 6 months
- HIV+ women
Key exclusion criteria (5 listed)
- Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
- Women with a negative HPV test
- Patients incapable of giving informed consent
- Women with a history of cervical cancer
- Pelvic exam concerning for cervical cancer or cervical infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pocket ColposcopeBoth arms will receive treatment in order to prevent cervical cancer. However, the intervention using the pocket colposcope device will be used on half the enrolled subjects. | Device | Pocket Colposcope |
| Standard of Care ColposcopyVIA and VILI as previously described, | Procedure or surgery | Standard of Care |
Primary outcome
Percent of Exams With Lesions Identified
Time frame: Baseline
The primary endpoint was the diagnostic accuracy of VIA versus the Pocket Colposcope for detecting CIN2+ lesions.
Sensitivity
Time frame: Baseline
Sensitivity of Pocket vs VIA
Specificity
Time frame: Baseline
Specificity of Pocket vs VIA
Negative Predictive Value (NPV)
Time frame: Baseline
Negative predictive value (NPV) of Pocket vs VIA
Positive Predictive Value (PPV)
Time frame: Baseline
Positive predictive value (PPV) of Pocket vs VIA
5 secondary outcomes
Percent of Participants Who Reported Having No Awareness About Cervical Cancer and Cervical Cancer Prevention, Assessed by Questionnaire
Time frame: baseline
Percent of Providers Who Reported Experiencing no Challenges During the Exam
Time frame: baseline
Percent of Participants Who Reported Experiencing Pain During Their Exam
Time frame: Baseline
Percent of Participants Who Expressed Confidence in Their Provider's Assessment
Time frame: Baseline
Percent of Participants Who Would Recommend the Exam to a Friend
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Huchko, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pocket Colposcope in people with Cervical Cancer and HPV Infection, run by Duke University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Exams With Lesions Identified (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.