DeepView SnapShot Portable (DV-SSP): Device Training Study

NCT05023135 | Completed FDA Device

• 1 other identifier: CT-2021-01--CSP-10
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 11

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.

Conditions

Burns; Wound Heal

Outcome Measures

Primary Outcomes (1)

• Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient

  Test that the Burn Segmentation Algorithm's predicted severe burn area (i.e., deep second degree and third degree) within an image of a burn injury, will be equivalent to the true area of severe burn as determined by the expert panel. The analysis for this study would only include data obtained from participants in the study.

  3 weeks

Study Arms (1)

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 SnapShot Portable (DV-SSP)

Interventions

DeepView SnapShot Portable (DV-SSP) DEVICE

DV-SSP assistive imaging to collect observational data

Subjects with Thermal Burn Injury

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SpectralMD: lead

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Valleywise Health

Phoenix, Arizona, 85008, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital

New Orleans, Louisiana, 70118, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

St. Christopher's Childrens Hospital

Philadelphia, Pennsylvania, 19134, United States

Location

University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: September 7, 2021
• Primary Completion: April 9, 2023
• Study Completion: April 30, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

US (11)