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Point-spectroscopy Trial

Sponsor
MolecuLight Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05183698
Collaborator
(none)
50
Enrollment
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Evaluation and characterization of autofluorescence signals of tissue in and around wounds as identified by MolecuLight fluorescence image.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Evaluate and characterize autofluorescence signals of tissue components in and around wounds identified by MolecuLight FL images using a point spectrometer. The fluorescence spectroscopy data will yield quantitative spectral information, including the relative intensity and emission peak of the biological autofluorescence signatures.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Spectroscopic Assessment of Autofluorescent Signatures of Tissue in and Around Wounds Identified by MolecuLight i:X Imaging Device
    Anticipated Study Start Date :
    Jan 10, 2022
    Anticipated Primary Completion Date :
    May 10, 2022
    Anticipated Study Completion Date :
    Dec 10, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Spectra of autofluorescent signatures of tissue in and around the wounds [2 months]

      Spectral characterization (i.e. emission curve including intensity) of the autofluorescence signal from wound tissue and surrounding tissue will be catalogued from all 50 study participants.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients presenting with acute or chronic wounds

    • 18 years or older

    • Willing to consent

    Exclusion Criteria:

    • Treatment with an investigational drug within 1 month of enrolment

    • Any contra-indication to regular wound care

    • Inability or unwillingness to consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • MolecuLight Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MolecuLight Inc.
    ClinicalTrials.gov Identifier:
    NCT05183698
    Other Study ID Numbers:
    • 20-002
    First Posted:
    Jan 11, 2022
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Jan 11, 2022