A Prospective Evaluation of Clinical Equivalence Between iX and PID

A Prospective Evaluation of Clinical Equivalence Between i:X and PID

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03967405

Enrollment

Registered

2019-05-30

Start date

2019-08-01

Completion date

2021-03-15

Last updated

2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound

Keywords

Wound, Imaging

Brief summary

Patients with chronic wounds will be imaged using 2 imaging devices. Two types of images will be acquired with each device, a standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Detailed description

Patients (n = 50) with chronic wounds will be imaged using 2 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 2 imaging devices will be compared off-line by many interpreters to assess for any differences in the images that would alter a clinical decision.

Interventions

DEVICEMolecuLight PID

Hand-held, real-time fluorescence imaging device

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) of unknown infection status 2. 18 years of age or older

Exclusion criteria

1. Treatment with an investigational drug within 1 month before study enrollment 2. Subjects with recent (\<30 days) biopsy or curettage of target wound 3. Subjects with wounds that cannot be completely imaged by study device due to anatomic location 4. Unable or unwilling to consent

Design outcomes

Primary

Measure	Time frame	Description
Concordance	2 months	The inter-reader concordance of the iX and PID FL-images together is not less than the inter-reader concordance of the iX FL-images alone.

Secondary

Measure	Time frame	Description
Sensitivity and Specificity	2 months	Sensitivity and specificity for detection of moderate/heavy bacterial load of PID FL-images to be equal to or greater than that of i:X FL-images when validated by microbiology gold truth

Other

Measure	Time frame	Description
Bacterial Load quantification by sampling	2 months	Quantify difference in bacterial load reported by sampling using standard Levine technique (swabbing) compared to FL image-guided curettage scraping.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026