A Prospective Evaluation of Clinical Equivalence Between iX and PID

Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03967405
• Other study ID #: 19-002
• Status: Active, not recruiting
• Start date: August 1, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2020
• Source: MolecuLight Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound

Intervention

Device:
• MolecuLight PID
Hand-held, real-time fluorescence imaging device

Locations

Country	Name	City	State
Canada	Judy Dan Research and Treatment Center	North York	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
MolecuLight Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bacterial Load quantification by sampling	Quantify difference in bacterial load reported by sampling using standard Levine technique (swabbing) compared to FL image-guided curettage scraping.	2 months
Primary	Concordance	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.	2 months
Secondary	Sensitivity and Specificity	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	2 months