Evaluation of PerioMonitor for Detection of Oral Inflammatory (OI) in Human Subjects in Medical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Comfort to participants
研究概览
简要总结
The purpose of the study is to evaluate the usability of PerioMonitor™ in a medical clinic environment and to evaluate the effectiveness of a referral system from physicians to dentists for patients identified with high oral inflammation.
PerioMonitor™ is an In Vitro Diagnostic (IVD) device intended as an aid in the detection of oral inflammation in individuals of 18 years and older. This test is intended for use at point-of-care (POC) sites by health care professionals (e.g., physicians, nurses, medical assistants, dentists, dental hygienists, and dental assistants).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject fluent in English
- •subject has signed the ICF
排除标准
- •subject with altered mental status/inability to provide informed consent or follow the procedure of the Study
- •Previous enrolment into the current Study
- •Patients with known severe oral diseases such as oral cancer
结局指标
主要结局
Comfort to participants
时间窗: Day 0
Comfort to participants with sample collection (Yes/No). The Overall ratio (%) of discomfort ('No') as well as the ratio per operator will be measured.
Use error
时间窗: Day 0
Any issue encountered with collection of specimens and/or test reading. The overall ratio (%) of tests with use errors as well as the ratio per operator will be measured
Ratio (%) of valid tests/performed tests
时间窗: Day 0
The ratio of valid PerioMonitor tests (with no issue reported) over the total number of tests performed
Ease of Test Performance
时间窗: Day 0
The Ease-of-Test Performance will be evaluated by a 5-question questionnaire
次要结局
- Proportion (%) participants referred to a Dental Specialist(12-Month)
- Proportion (%) of participants referred to a Dental Specialist(6-Month)
- Proportion (%) of compliant participants with the recommended visit to a Dental Specialist(12-Month)