An Open Label Clinical Investigation to Assess and Measure the Functionality of Menstrual Fluid Collection Device- M- StripTM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1.Proportion of adequate samples for evaluation out of total samples collected.
研究概览
简要总结
The menstrual fluid collection device-M-StripTM intends to collect, store, and transport menstrual blood noninvasively for diagnostic, medical and research applications. According to the statistics in India, it is estimated that every year 1,23,907 women ages 15 years and older are diagnosed with cervical cancer and 77,348 die from the disease. Cervical cancer ranks as the 2nd most frequent cancer among women in India and the 2nd most frequent cancer among women between 15 and 44 years of age.1 Diseases like Human Papilloma Virus (HPV) can also spread through intimate skin-to-skin contact. Cervical cancer may be detected at early the stage stages by cervical cytology or HPV testing.2 There are studies demonstrating the possibility of using the menstrual blood as an HPV screening modality for cervical cancer.9 The menstrual fluid collection device-M-Strip can play a major role in overcoming the disadvantages of endometrial biopsy and helps in the diagnosis of HPV using the menstrual blood from the M-StripTM.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Healthy women volunteers are chosen aged 30 and 55 years.
- •2.Subjects who are willing to participate in the study and sign the informed consent document and comply with the trial procedure.
- •3.Subjects who are compliant with the study.
排除标准
- •1.Pregnant and lactating women.
- •2.Clinical evidence of any serious systemic disease or acute illness, in the clinical opinion of the Investigator.
- •3.Subjects who are surgically sterile or have attained menopause (if they had their last menstruation more than 2 years back.
- •4.Subjects who were previously included or had participated in any other clinical study within 30 days prior to the date of consent.
结局指标
主要结局
1.Proportion of adequate samples for evaluation out of total samples collected.
时间窗: Day 1, Day 2 & Day 3
2.Concordance between HPV positive samples in Menstrual blood collected using M StripTM versus conventional method
时间窗: Day 1, Day 2 & Day 3
次要结局
- 1.Laboratory analysis and confirmation of the menstrual blood samples collected on the first three days of menstruation.(2. The prevalence of the different high risk HPV subtypes and the associated)
研究者
Dr Somesh Chandra
Sterling Hospital