Shortwave Infrared Surgical Imaging Device Study

Brief summary (registry, in English)

The goal of this observational study is to perform an in-human assessment of an investigational shortwave infrared (SWIR) imaging device, aimed to enhance the visualization of critical anatomical structures during surgical procedures in non-vulnerable adults between the ages of 18 and 70+. The main questions are to 1) evaluate the feasibility of utilizing SWIR imaging technology within a clinical environment, 2) ascertain the safety of the device, ensuring that its application does not interfere with or alter the established standard of care, and (3) collect preliminary human data that will inform and support the design of future research investigations. It is not the goal of this study to deviate from the standard of care, nor will it influence the diagnostic or therapeutic decisions made by the clinical team. The central hypothesis of this study is that shortwave infrared (SWIR) imaging will effectively visualize critical anatomical structures, such as nerves, ureters, and bile ducts, in human subjects. This expectation is grounded in favorable preclinical results observed in porcine models and cadaveric studies. Additionally, the investigators aim to demonstrate that the use of SWIR imaging can be accomplished without introducing additional risks to patients or disrupting established surgical workflows. After study subjects have consented, the participating surgeons will use the imaging device to visualize key structure seen during the procedure for no more than 10 minutes per case. The surgeons are also asked to complete a device assessment for each case.

What you commit to

• Study type: Observational
• Planned participants: 50
• From 29 May 2026 to the primary completion date, 11 Oct 2026
• 6 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

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