Shortwave Infrared Surgical Imaging Device Study

NCT07744425 | Enrolling By Invitation DMC

• 1 other identifier: 1393658
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Type of structures identified

  Anatomic structures seen through the device during surgery

  May 29, 2026 to October 11, 2026

Secondary Outcomes (1)

• Qualitative assessment of device functionality and performance by surgeons

  May 29, 2026 to October 11, 2026

Study Arms (1)

FIH Cohort

Non-vulnerable adults (ages 18+)

Device: Observational study of SWIR imaging device in surgery

Interventions

Observational study of SWIR imaging device in surgery DEVICE

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

FIH Cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients, excluding vulnerable populations, undergoing surgeries who are able to provide voluntary, informed consent.

You may qualify if:

• Non-vulnerable adults

You may not qualify if:

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

Sponsors & Collaborators

• Cision Vision, Inc.: lead
• Stanford University: collaborator
• Johns Hopkins University: collaborator
• Endeavor Health: collaborator
• University of Notre Dame: collaborator
• Massachusetts Institute of Technology: collaborator

Study Sites (6)

Stanford Health Care

Palo Alto, California, 94304, United States

Location

Endeavor Health - Evanston Hospital

Evanston, Illinois, 60035-2558, United States

Location

Endeavor Health - Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

Endeavor Health - Highland Park Hospital

Highland Park, Illinois, 60035-2558, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Cholecystitis; Bronchiolitis Obliterans Syndrome; Hyperparathyroidism, Primary; Thyroid Diseases

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Lisa M. Knowlton, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 4, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): October 11, 2026
• Study Completion (Estimated): October 11, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

US (6)