Deepview HHF Training and Validation Label Expansion Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 主要终点
- Label Expansion Through Imaging HHF
研究概览
简要总结
The purpose of this Study is to help expand the use of the DeepView AI System so that it can assess burn injuries on the hands, head/face, and feet. To do this, the Study will collect new images of burns in these areas. Some of these images will be used to improve and retrain the AI system, while others will be used to test how well the updated system performs. The images for both purposes will be collected at the same time. The new images from the hands, head/face, and feet will then be combined with existing images from other body areas. This will allow researchers to determine whether the updated AI system performs as well as, or better than, previous versions of the technology. For participants with Study Burns requiring surgical excision, the Study site clinician will collect punch biopsies from the Study Burn according to a standardised burn wound punch biopsy collection.
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, have a witnessed verbal consent, family discussion if intubated and retrospective consent for those that are intubated
- •Life expectancy > 1 month
- •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 adult or paediatric participants is 0.25% TBSA per region
- •Have burn(s) on the head, hands and/or feet that meet the criteria for a Study Burn. If multiple regions meet the Study Burn criteria, per the discretion of the Investigator, all Study Burn regions should be included.
排除标准
- •Sepsis at the time of enrolment
- •Infection of the burn wound at the time of enrolment
- •Immunosuppression / radiation / chemotherapy < 3 months prior to enrolment
- •Concurrent use of investigational products with a known effect on the burn sites; and/or imaging
- •Concurrent use of products such as chemical debriding agents, skin substitutes and others that the principal investigator deems will have an impact on the image quality and healing potential of a Study Burn
- •Any condition that, in the opinion of the Investigator, may prevent compliance with the study requirements or compromise Participant safety
- •Participants without a burn on the hands, feet, head or neck, or burns located on these regions only on the palmar or plantar surfaces
- •Chemical or any other non-thermal burns
- •8. Participants anticipated to or undergoing enzymatic debridemen9
结局指标
主要结局
Label Expansion Through Imaging HHF
时间窗: Time of Injury through 21 Day Healing Assessment
The number of Hand, Head, Feet (HHF) images collected with the DeepView AI System (DV) is the primary objective of this study in order to support the expansion of the intended use of the DV System. These images are used to assess the ground truth using a panel of expert burn surgeons.
次要结局
未报告次要终点