Shortwave Infrared Surgical Imaging Device Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational study of SWIR imaging device in surgery.
- Who it may be relevant to
- Registry conditions: Cholecystitis, Cholecystitis, Chronic, Chronic Calculous Cholecystitis, Primary Hyperparathyroidism. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Tissue Recognition and Depth-Sensing With A.I. Powered Hyperspectral Confocal Shortwave Infrared Imaging
Overview
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.
Interventions
- Device Observational study of SWIR imaging device in surgery
SWIR surgical imaging device to help surgeons visualize key structures during procedures
Primary outcome measures
- Type of structures identified [Time frame: May 29, 2026 to October 11, 2026]
Secondary outcome measures (1)
- Qualitative assessment of device functionality and performance by surgeons [Time frame: May 29, 2026 to October 11, 2026]
Eligibility criteria
Inclusion criteria
Non-vulnerable adults
Exclusion criteria
Vulnerable adults who are not able to provide voluntary, informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 6 centers
- Stanford Health Care — Palo Alto
- Endeavor Health - Evanston Hospital — Evanston
- Endeavor Health - Glenbrook Hospital — Glenview
- Endeavor Health - Highland Park Hospital — Highland Park
- Johns Hopkins Bayview Medical Center — Baltimore
- Johns Hopkins Hospital — Baltimore
Identifiers
NCT: NCT07744425 · 1393658