A Prospective Evaluation of Clinical Equivalence Between iX and PID

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

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.

Study Overview

• Status: Unknown
• Conditions: Wound
• Intervention / Treatment: Device: MolecuLight PID

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • North York, Ontario, Canada, M2R 1N5
      • Judy Dan Research and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic wounds

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MolecuLight Inc.
• Investigators: Principal Investigator: Ronald Linden, Judy Dan Research and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): March 15, 2021
• Study Completion (Anticipated): March 15, 2021

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Imaging; Wound
• Other Study ID Numbers: 19-002 (Zealand Pharma)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to disseminate information to patients. If patients ask for their information then they will be provided a response with the most up to date information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No