ClinicalTrials.gg
Not yet recruitingNCT07677657UK HHFUpdated Oct 7, 2026

Deepview HHF Training and Validation Study

An observational study in Burns, Burn Injury and Diagnostic, sponsored by SpectralMD. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by SpectralMD · Observational

Updated Oct 7, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
280
Sex
All
01

Study summary

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.

02

Conditions studied

  • Burns
  • Burn Injury
  • Diagnostic

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03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 280 is above the median of 64 across 163 observational studies indexed under Burns.

Browse Burns studies →

Lead sponsor

SpectralMD is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Willing and able to give , have a witnessed verbal consent, family discussion if intubated and retrospective consent for those that are intubated
  2. > 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

Exclusion Criteria:

  1. Sepsis at the time of enrolment
  2. Infection of the burn wound at the time of enrolment
  3. / radiation / chemotherapy \< 3 months prior to enrolment
  4. Concurrent use of 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

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
280 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceDeepView 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.

06

What researchers measure

Primary outcomes

  1. 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 frame: Time of Injury through 21 Day Healing Assessment

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Start date
Sep 1, 2026→Oct 5, 2026
Oct 7, 2026
Primary completion
Apr 1, 2027→Jun 1, 2027
Oct 7, 2026
Study completion
May 1, 2027→Jul 1, 2027
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Start date Sep 1, 2026→Oct 5, 2026
    Primary completion Apr 1, 2027→Jun 1, 2027
    Study completion May 1, 2027→Jul 1, 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07677657
Lead sponsor
SpectralMD
Responsible party
Sponsor
First posted
Jul 1, 2026
Start date
Oct 5, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Alexandra Krajcevska, MTM
Contact
krajcevska@spectralmd.com
972-499-4934
Taylor Frank
Contact
frank@spectralmd.com

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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