Deepview HHF Training and Validation Study (UK HHF)

Deepview HHF Training and Validation Label Expansion 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns; Burn Injury; Diagnostic
• Intervention / Treatment: Device: DeepView AI System

• Study Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Alexandra Krajcevska, MTM; Phone Number: 972-499-4934; Email: krajcevska@spectralmd.com
• Study Contact Backup: Name: Taylor Frank; Email: frank@spectralmd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects enrolled in this study will be recruited at the designated Study Site within 72 hours of suffering a thermal burn injury. Adult and pediatric Subjects with burns from one or more of the defined burn severities will be enrolled. All Subjects must meet the specified inclusion criteria.

Description

Inclusion Criteria:

1. Willing and able to give informed consent, have a witnessed verbal consent, family discussion if intubated and retrospective consent for those that are intubated
2. Life expectancy > 1 month
3. Thermal burn mechanism (flame, scald, or contact)
4. The Study Burn(s) occurred less than 72 hours prior to the time of first imaging
5. Minimum burn wound size for adult or paediatric participants is 0.25% TBSA per region
6. 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:

1. Sepsis at the time of enrolment
2. Infection of the burn wound at the time of enrolment
3. Immunosuppression / radiation / chemotherapy < 3 months prior to enrolment
4. Concurrent use of investigational products with a known effect on the burn sites; and/or imaging
5. 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
6. Any condition that, in the opinion of the Investigator, may prevent compliance with the study requirements or compromise Participant safety
7. Participants without a burn on the hands, feet, head or neck, or burns located on these regions only on the palmar or plantar surfaces
8. Chemical or any other non-thermal burns

8. Participants anticipated to or undergoing enzymatic debridemen9

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects with Thermal Burn Injury; An initial imaging with the DV-SSP would be completed at the Study Site within 72 hours of suffering a thermal burn injury.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Label Expansion Through Imaging HHF	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.	Time of Injury through 21 Day Healing Assessment

Collaborators and Investigators

• Sponsor: SpectralMD

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease; Burns
• Other Study ID Numbers: CLA-PR-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes