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Post Market Clinical Followup of MolecuLight i:X's PPV to Predict Presence of Bacteria in Wounds

NCT03091361 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-01-18

Study results available
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Summary

This is a non-randomized, single-blind post market clinical follow-up study for which 50 patients will be imaged at the Judy Dan Research and Treatment Centre who present with a chronic and are receiving standard wound care treatment. The i:X imaging device visualizes fluorescing bacteria in real-time. The device will be used as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (with curettage scraping). The overall objective of this work is to evaluate the positive predictive value (PPV) of the MolecuLight i:X Imaging Device in predicting the presence of bacteria in chronic wounds. The presence of bacteria will be determined micro-biologically by semi-quantitative culture analysis.

Conditions

  • Wounds and Injuries

Interventions

OTHER

imaging, no intervention

no intervention

Sponsors & Collaborators

  • MolecuLight Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Linden, MD · Judy Dan Research and Treatment Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-11-30
Completion
2017-02-28

Countries

  • Canada

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091361 on ClinicalTrials.gov