A Prospective, Pilot Evaluation of Device Equivalence

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

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-26

Study Completion Date

2019-01-02

Brief Summary

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Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

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Detailed Description

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Patients (n = 50) with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Conditions

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Wound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Fluorescence Imaging Device

Hand-held, real-time fluorescence imaging device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects (inpatient/outpatient) presenting with a wound
* Wound size less than 15 cm in length
* 18 years or older

Exclusion Criteria

* Treatment with an investigational drug within 1 month before study enrolment
* Subjects with recent (\<30 days) biopsy or curettage of target wound
* Subjects with wounds that cannot be completely imaged by study device due to anatomic location
* Unable or unwilling to consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No