NCT06458062

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,079

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Feb 2024Apr 2027

Study Start

First participant enrolled

February 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

June 10, 2024

Last Update Submit

January 8, 2026

Conditions

HPV InfectionCervical Cancer

Keywords

HPV testingcolposcopycervical cancer screening

Outcome Measures

Primary Outcomes (4)

  • Sensitivity of the Pocket CARE in detecting pre-cancer

    Sensitivity will be reported as a percentage

    Day of imaging (Day 1)

  • Specificity of the Pocket CARE in detecting pre-cancer

    Specificity will be reported as a percentage

    Day of imaging (Day 1)

  • Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer

    PPV will be reported as a percentage

    Day of imaging (Day 1)

  • Negative Predictive Value (NPV) of the Pocket CARE in detecting pre-cancer

    NPV will be reported as a percentage

    Day of imaging (Day 1)

Study Arms (1)

Pocket Assisted Colposcopy

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. Acetic acid may be reapplied between white and green imaging at the provider's discretion if acetowhitening diminishes. 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.

Device: Pocket Colposcope

Interventions

Pocket ColposcopeDEVICE

Each patient will receive treatment in order to prevent cervical cancer

Pocket Assisted Colposcopy

Eligibility Criteria

Age25 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pelvic exam concerning for cervical cancer or cervical infection
  • History of hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPapillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Megan Huchko, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Huchko, MD

CONTACT

919-684-8111megan.huchko@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 13, 2024

Study Start

February 15, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

KE(1)