Shortwave Infrared Surgical Imaging Device Study

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.

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Cholecystitis, Chronic Chronic Calculous Cholecystitis Digestive System Diseases Endocrine System Diseases Gallbladder Diseases Graft vs Host Disease Hyperparathyroidism Hyperparathyroidism, Primary Immune System Diseases Lung Diseases Lung Diseases, Obstructive Multinodular Goiter Organizing Pneumonia Parathyroid Diseases Primary Hyperparathyroidism Respiratory Tract Diseases Sigmoid Colon Diverticulitis Thyroid Diseases Thyroid and Parathyroid Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Health Care, Palo Alto, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Non-vulnerable adults

Exclusion criteria

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

Treatment and study plan

Observational study of SWIR imaging device in surgery

Device

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

Primary outcomes

Type of structures identified

Time frame: May 29, 2026 to October 11, 2026

Anatomic structures seen through the device during surgery

Secondary outcomes

Qualitative assessment of device functionality and performance by surgeons

Time frame: May 29, 2026 to October 11, 2026

These qualitative measures include the ease of use, visualization performance, and the perceived change in their confidence level in their decision-making process.

Sponsors and collaborators

Lead sponsor

Cision Vision, Inc.

Industry

Collaborators

Endeavor Health
Johns Hopkins University
Massachusetts Institute of Technology
Stanford University
University of Notre Dame

Registry information

Official study title

Tissue Recognition and Depth-Sensing With A.I. Powered Hyperspectral Confocal Shortwave Infrared Imaging

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Aug 4, 2026
Registry last updated: Aug 4, 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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