Shortwave Infrared Surgical Imaging Device Study

Summary

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.

Conditions

• Cholecystitis
• Cholecystitis, Chronic
• Chronic Calculous Cholecystitis
• Primary Hyperparathyroidism
• Sigmoid Colon Diverticulitis
• Multinodular Goiter
• Thyroid and Parathyroid Surgery

Interventions

DEVICE

Observational study of SWIR imaging device in surgery

SWIR surgical imaging device to help surgeons visualize key structures during procedures

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Endeavor Health

  collaborator OTHER

• University of Notre Dame

  collaborator OTHER

• Massachusetts Institute of Technology

  collaborator OTHER

• Cision Vision, Inc.

  lead INDUSTRY

Principal Investigators

• Lisa M. Knowlton, MD, MPH · Stanford University

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-29

Primary Completion

2026-10-11

Completion

2026-10-11

Countries

• United States

Study Locations