A Prospective Evaluation of Clinical Equivalence Between iX and PID

NCT03967405 | Unknown FDA Device

• 1 other identifier: 19-002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound

Keywords

Wound; Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity and Specificity

  2 months

Other Outcomes (1)

• Bacterial Load quantification by sampling

  2 months

Interventions

MolecuLight PID DEVICE

Hand-held, real-time fluorescence imaging device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic wounds

You may qualify if:

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

You may not qualify if:

• Treatment with an investigational drug within 1 month before study enrollment
• 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

Sponsors & Collaborators

• MolecuLight Inc.: lead

Study Sites (1)

Judy Dan Research and Treatment Center

North York, Ontario, M2R 1N5, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Ronald Linden

  Judy Dan Research and Treatment Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: August 1, 2019
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)