Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

NCT ID: NCT06921421

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2025-12-31

Brief Summary

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The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).

Detailed Description

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Conditions

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Burn Burn Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Spatial Frequency Domain Imaging

Spatial Frequency Domain Imaging captures at specific timepoints.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients 18 years of age or older
2. Thermal burns of any depth (superficial, deep partial thickness, or full thickness).

Exclusion Criteria

1. Patients less than 18 years of age
2. Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The United States Institute of Surgical Research

UNKNOWN

Sponsor Role collaborator

Modulated Imaging Inc.

INDUSTRY

Sponsor Role collaborator

The Metis Foundation

OTHER

Sponsor Role lead

Responsible Party

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Rodney Chan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodney Chan, MD

Role: PRINCIPAL_INVESTIGATOR

The Metis Foundation

Locations

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The United States Army Institute of Surgical Resarch

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Victoria Diaz, BSN

Role: CONTACT

210-201-2206

Facility Contacts

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Kristin Anselmo

Role: primary

2105691138

Other Identifiers

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MTEC-22-08-BDA-007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-25-017

Identifier Type: -

Identifier Source: org_study_id

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