Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,079
- 试验地点
- 1
- 主要终点
- Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer
研究概览
简要总结
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.
详细描述
Women undergo Pocket-Assisted VIA (PA-VIA) and green light imaging using the Pocket Colposcope. Women 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. Once we have obtained enough images to develop the CARE algorithm, it will also be used to assist the provider in diagnosis.
This record previously reflected only Phase 1 of Aim 3 of the grant. Phase 1 of Aim 3 was originally included within NCT04998318. The details for Phase 2 of Aim 3 were added to this record in September 2025 after approval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pocket Assisted Colposcopy
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.
干预措施: Pocket Colposcope (Device)
结局指标
主要结局
Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer
时间窗: Day of imaging (Day 1)
PPV will be reported as a percentage
Negative Predictive Value (NPV) of the Pocket CARE in detecting pre-cancer
时间窗: Day of imaging (Day 1)
NPV will be reported as a percentage
Sensitivity of the Pocket CARE in detecting pre-cancer
时间窗: Day of imaging (Day 1)
Sensitivity will be reported as a percentage
Specificity of the Pocket CARE in detecting pre-cancer
时间窗: Day of imaging (Day 1)
Specificity will be reported as a percentage
次要结局
未报告次要终点