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Enrolling by invitationNCT07744425Updated Aug 4, 2026

Shortwave Infrared Surgical Imaging Device Study

An observational study in Cholecystitis, Cholecystitis, Chronic and Chronic Calculous Cholecystitis, sponsored by Cision Vision, Inc.. Enrolling by invitation at 6 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Cision Vision, Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cholecystitis
  • Cholecystitis, Chronic
  • Chronic Calculous Cholecystitis
  • Primary Hyperparathyroidism
  • Sigmoid Colon Diverticulitis
  • Multinodular Goiter
  • Thyroid and Parathyroid Surgery
03

In context

Cholecystitis

192 studies on the registry are indexed under Cholecystitis; 36 are open to participants now.

This study's planned enrollment of 50 is below the median of 222 across 55 observational studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

This is the only study on the registry with Cision Vision, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Non-vulnerable adults

Exclusion criteria

Exclusion Criteria:

Vulnerable adults who are not able to provide voluntary, .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • FIH Cohort

    Non-vulnerable adults (ages 18+)

    Device: Observational study of SWIR imaging device in surgery

Interventions

  • DeviceObservational study of SWIR imaging device in surgery

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

06

What researchers measure

Primary outcomes

  1. Type of structures identified

    Anatomic structures seen through the device during surgery

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

Secondary outcomes

  1. Qualitative assessment of device functionality and performance by surgeons

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

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

07

Study locations

6 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07744425
Lead sponsor
Cision Vision, Inc.
Collaborators
Stanford University, Johns Hopkins University, Endeavor Health, University of Notre Dame, Massachusetts Institute of Technology
Responsible party
Sponsor
First posted
Aug 4, 2026
Start date
May 29, 2026
Primary completion
Oct 11, 2026 (estimated)
Completion
Oct 11, 2026 (estimated)
Last update
Aug 4, 2026

Study contacts

Lisa M. Knowlton, MD, MPH
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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