Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Cervical Cancer
- 发起方
- Brookdale University Hospital Medical Center
- 入组人数
- 618
- 试验地点
- 1
- 主要终点
- Detection of precancerous cervical lesions or cervical cancer
- 最后更新
- 11年前
概览
简要总结
A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.
研究者
Michele Follen
Chair of Department of Obstetrics and Gynecology
Brookdale University Hospital Medical Center
入排标准
入选标准
- •Women who are at least 18 years old
- •Women who are not pregnant as confirmed by a urine test
- •Women who are not breastfeeding
- •Women who understand the study procedures and can provide written informed consent
排除标准
- •Women who do not meet the inclusion criteria
- •Women who have had a hysterectomy
结局指标
主要结局
Detection of precancerous cervical lesions or cervical cancer
时间窗: At point of care for colposcopy or treatment with LEEP (5 minutes).
Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the handheld imaging research device will also be used to capture cervical images. The images will be analyzed and compared to the biopsies obtained. The imaging device will not be used to make a diagnosis. As part of the research study, one or two additional biopsies will be obtained if the patient agrees. These additional biopsies will serve as the control tissue, since they will be taken from tissue that appears normal through the colposcope.