Shortwave Infrared Surgical Imaging Device Study

Part of paid clinical trials in Palo Alto, California.

Sponsor
Cision Vision, Inc.
Study ID
NCT07744425
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Observational study of SWIR imaging device in surgery — DEVICE
    SWIR surgical imaging device to help surgeons visualize key structures during procedures

Study Details

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 Dates

First listed
Aug 4, 2026
Start date
May 29, 2026
Status verified
Jul 2026
Primary completion
Oct 11, 2026
Completion
Oct 11, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: FIH Cohort
    Non-vulnerable adults (ages 18+)

Primary Outcome Measure

Type of structures identified [ Time Frame: May 29, 2026 to October 11, 2026 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Stanford Health CarePalo AltoCalifornia94304-
Endeavor Health - Evanston HospitalEvanstonIllinois60035-2558-
Endeavor Health - Glenbrook HospitalGlenviewIllinois60026-
Endeavor Health - Highland Park HospitalHighland ParkIllinois60035-2558-
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224-
Johns Hopkins HospitalBaltimoreMaryland21224-

Find similar trials in Palo Alto, CA

By research site
Stanford Health Care· Palo Alto, CAEndeavor Health - Evanston Hospital· Evanston, ILEndeavor Health - Glenbrook Hospital· Glenview, ILEndeavor Health - Highland Park Hospital· Highland Park, ILJohns Hopkins Bayview Medical Center· Baltimore, MDJohns Hopkins Hospital· Baltimore, MD

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