Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07677657

Deepview HHF Training and Validation Study

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Participants anticipated to or undergoing enzymatic debridemen9

Treatment and study plan

DeepView AI System

Device

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.

Primary outcomes

  1. Label Expansion Through Imaging HHF

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Krajcevska, MTM

CONTACT

[email protected]

972-499-4934

Taylor Frank

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

SpectralMD

Industry

Registry information

Official study title

Deepview HHF Training and Validation Label Expansion Study

Acronym: UK HHF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.