Clinical trial NCT05023135: DeepView SnapShot Portable (DV-SSP): Device Training Study
Official title: DeepView SnapShot Portable (DV-SSP): Device Training Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Wound Heal
Lead sponsor: SpectralMD
Sponsor class: INDUSTRY
First posted: 2021-08-26
Enrollment: 251
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.


Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so;
* Life expectancy \> 6 months;
* Thermal burn mechanism (flame, scald, or contact);
* The Study Burn(s) occurred less than 72 hours prior to the time of first imaging; and
* Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region
* For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn.
* For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn

Exclusion Criteria:

* Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints;
* Subject has burns involving \> 50% total body surface area (TBSA);
* Sepsis at the time of enrollment;
* Immunosuppression/radiation/chemotherapy \< 3 months prior to enrollment;
* Concurrent use of investigational products with a known effect on the burn sites; and/or
* Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.

Primary outcomes:
measure: Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Valleywise Health
state: Arizona
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Children's Hospital
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: St. Christopher's Childrens Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
References: