Deepview HHF Training and Validation Study

Официальное название

Deepview HHF Training and Validation Label Expansion Study

Обзор

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.

Вмешательства

• Устройство DeepView AI System
  DeepView is an assistive imaging device which will be used to collect observational data as part of the study. The device will be blinded and only used for data collection.

Первичные конечные точки

• Label Expansion Through Imaging HHF [Срок оценки: Time of Injury through 21 Day Healing Assessment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07677657 · CLA-PR-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗