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Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds

A Prospective, Single-blind, Multi-center Clinical Study Evaluating the Use of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03540004
Enrollment
367
Registered
2018-05-30
Start date
2018-05-23
Completion date
2020-12-30
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

Brief summary

This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and may be used to guide the targeted sampling of a wound (using a conventional punch biopsy method).

Interventions

The i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.

Sponsors

SerenaGroup, Inc.
CollaboratorNETWORK
MolecuLight Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male and female subjects presenting at an advanced outpatient wound care clinic with wound(s) (e.g. DFU, VLU, PU, SSI) * 18 years or older

Exclusion criteria

* Treatment with an investigational drug within 1 month before study enrolment * Subjects with recent (\<30 days) biopsy of target wound * Subjects with wounds that cannot be completely imaged by study device due to anatomic location * Inability to consent * Any contra-indication to routine wound care and/or monitoring

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of identifying wounds with moderate/heavy bacterial load as measured by sensitivity and specificity.1 yearSuperiority in sensitivity of clinical signs and symptoms (CSS) and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone to identify wounds with moderate/heavy bacterial load Non-Inferiority of specificity of CSS and fluorescence imaging using MolecuLight i:X (CSS + i:X) vs. CSS alone with region of indifference of 10% to identify wounds with moderate/heavy bacterial load

Secondary

MeasureTime frame
Estimation of sensitivity and specificity of MolecuLight i:X alone1.5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026