NCT05023135已完成不适用
DeepView SnapShot Portable (DV-SSP): Device Training Study
SpectralMD11 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2021年9月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 11
- 主要终点
- Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient
研究概览
简要总结
The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing 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; and
- •Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region
- •For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn.
- •For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn
排除标准
- •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;
- •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
Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient
时间窗: 3 weeks
Test that the Burn Segmentation Algorithm's predicted severe burn area (i.e., deep second degree and third degree) within an image of a burn injury, will be equivalent to the true area of severe burn as determined by the expert panel. The analysis for this study would only include data obtained from participants in the study.
次要结局
未报告次要终点
研究者
研究点 (11)
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