Shortwave Infrared Surgical Imaging Device Study

Enrolling by invitation

Conditions studied: Cholecystitis, Cholecystitis, Chronic, Chronic Calculous Cholecystitis, Primary Hyperparathyroidism, Sigmoid Colon Diverticulitis, Multinodular Goiter, Thyroid and Parathyroid Surgery

In brief

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.

Key facts

Study ID

NCT07744425

Run by

Cision Vision, Inc.

People needed

50

Starts

2026-05-29

Expected to finish

2026-10-11

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-vulnerable adults

You may not qualify if…

• Vulnerable adults who are not able to provide voluntary, informed consent.

Where it is running

• Stanford Health Care — Palo Alto, California, United States
• Endeavor Health - Evanston Hospital — Evanston, Illinois, United States
• Endeavor Health - Glenbrook Hospital — Glenview, Illinois, United States
• Endeavor Health - Highland Park Hospital — Highland Park, Illinois, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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