DeepView Snapshot Handheld (DV-H) Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol
研究概览
简要总结
his study is being done to collect pictures of burns using an investigational device called the Spectral MD Deep View Snapshot Handheld (DV-H), similar to a camera. The data collected will be used to assess the performance of the DV-H device, and to determine the device's ability to differentiate healing versus non-healing burn tissue. This device, if approved, is expected to give caregivers a better understanding of what parts of burn wounds will likely not heal on their own and as a tool used by the military in the field. This current study involves the collection of images over the course of your clinical treatment and follow-up according to your routine standard of care. The device will not be used to diagnose or prescribe treatment for your burn
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.Age >18 years and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so;
- •Life expectancy > 6 months;
- •Thermal burn mechanism (flame, scald, or contact);
- •The Study Burn(s) occurred less than 72 hours prior to the time of first imaging;
- •Minimum burn wound size for patients is 0.5% TBSA per region
- •Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn; and
排除标准
- •Patients will be excluded if any of the following conditions apply:
- •Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints;
- •Subject has burns involving > 50% total body surface area (TBSA);
- •Sepsis at the time of enrollment determined by diagnosis made by Principal Investigator or Sub-Investigator;
- •Immunosuppression/radiation/chemotherapy < 3 months prior to enrollment;
- •Concurrent use of investigational products with a known effect on the burn sites; and/or
- •Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.
结局指标
主要结局
DeepView Snapshot Handheld (DV-SSH) Comparison Study Protocol
时间窗: 3 months
The primary objective of this study is to demonstrate that the proposed SA-MSI sensor is equivalent or better than the current LC-MSI sensor. To conduct this test, we will compare the performance of the burn assessment AI algorithm using the image sensor as input data to the same Algorithm using the lens cluster data as an input.
次要结局
未报告次要终点