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OpenTrials
Completed

NCT Number: NCT07646938

MolecuLight All-in-One Oxygenation Clinical Utility

This is a prospective, clinical evaluation of the MolecuLightDX+ with OxySight Module in wound care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SerenaGroup Monroeville

Monroeville, Pennsylvania, 15146, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients presenting with a wound
  • A wound is > 1 cm2 in area
  • 18+ years old
  • Willing to consent

Exclusion criteria

  • Contraindication to debridement
  • Undergoing radio- or chemotherapy
  • Wound located in a difficult to image location
  • Any condition deemed by the investigator to interfere with safety or data validity
  • Inability or unwillingness to consent

Treatment and study plan

MolecuLightDX+ with OxySight Module

Device

MolecuLightDX+ with OxySight Module is an imaging device intended to acquire fluorescence, oxygenation, thermal, and measurement images of wounds.

Primary outcomes

  1. Tissue oxygenation informing fluorescence-guided debridement

    Time frame: up to 1 month

    Evaluate the feasibility of using tissue oxygenation (StO2) to further inform fluorescence-guided debridement.

  2. Tissue oxygenation changes before and after debridement

    Time frame: up to 1 month

    Observe and quantify changes in tissue oxygenation (StO2) from before to immediately after fluorescence-guided debridement.

Sponsors and collaborators

Lead sponsor

MolecuLight Inc.

Industry

Registry information

Official study title

A Prospective, Clinical Evaluation of the MolecuLightDX+ With OxySight Module to Observe the Clinical Utility of Tissue Oxygenation, Bacterial Fluorescence and Thermal Signatures

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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