CholecystitisNCT07744425
Shortwave Infrared Surgical Imaging Device Study
An observational study of Cholecystitis and Cholecystitis, Chronic, run by Cision Vision, Inc. at 6 sites in United States.
Trial 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+. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholecystitis, Cholecystitis, Chronic, Chronic Calculous Cholecystitis
- What is being tested?
- Observational study of SWIR imaging device in surgery
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 May 2026to 11 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients, excluding vulnerable populations, undergoing surgeries who are able to provide voluntary, informed consent.
Who may be able to join
- Non-vulnerable adults
Who cannot join
- Vulnerable adults who are not able to provide voluntary, informed consent.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Endeavor Health - Evanston Hospital
Evanston, Illinois, 60035-2558
Endeavor Health - Glenbrook Hospital
Glenview, Illinois, 60026
Endeavor Health - Highland Park Hospital
Highland Park, Illinois, 60035-2558
Stanford Health Care
Palo Alto, California, 94304
About this study
Official title: Tissue Recognition and Depth-Sensing With A.I. Powered Hyperspectral Confocal Shortwave Infrared Imaging
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.
Read more
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, Cholecystitis, Chronic, Chronic Calculous Cholecystitis, Primary Hyperparathyroidism, Sigmoid Colon Diverticulitis, Multinodular Goiter
- Being tested
- Observational study of SWIR imaging device in surgery
- Medical subject headings
- Cholecystitis, Bronchiolitis Obliterans Syndrome, Hyperparathyroidism, Primary, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study of SWIR imaging device in surgeryDevice
SWIR surgical imaging device to help surgeons visualize key structures during procedures
| Study group | Role | What they receive |
|---|---|---|
| FIH Cohort | Non-vulnerable adults (ages 18+) Receives: Device: Observational study of SWIR imaging device in surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of structures identified
Anatomic structures seen through the device during surgery
Measured: 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.
Measured: May 29, 2026 to October 11, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start29 May 2026
- Primary completion11 Oct 2026 (estimated)
- Study completion11 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cision Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, Johns Hopkins University, Endeavor Health, University of Notre Dame, Massachusetts Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Lisa M. Knowlton, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744425
- Sponsor's protocol ID
- 1393658
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Recognition and Depth-Sensing With A.I. Powered Hyperspectral Confocal Shortwave Infrared Imaging
- ClinicalTrials.gov ID
- NCT07744425
- Acronym / sponsor ID
- 1393658
- Conditions
- Cholecystitis, Cholecystitis, Chronic, Chronic Calculous Cholecystitis, Primary Hyperparathyroidism, Sigmoid Colon Diverticulitis, Multinodular Goiter
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cision Vision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, Johns Hopkins University, Endeavor Health, University of Notre Dame, Massachusetts Institute of Technology
- Study start
- 29 May 2026 (actual)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 11 Oct 2026 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FIH Cohort | – | Device: Observational study of SWIR imaging device in surgeryNon-vulnerable adults (ages 18+) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, excluding vulnerable populations, undergoing surgeries who are able to provide voluntary, informed consent.
Key inclusion criteria (1 listed)
- Non-vulnerable adults
Key exclusion criteria (1 listed)
- Vulnerable adults who are not able to provide voluntary, informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study of SWIR imaging device in surgerySWIR surgical imaging device to help surgeons visualize key structures during procedures | Device | FIH Cohort |
Primary outcome
Type of structures identified
Time frame: May 29, 2026 to October 11, 2026
Anatomic structures seen through the device during surgery
1 secondary outcome
Qualitative assessment of device functionality and performance by surgeons
Time frame: May 29, 2026 to October 11, 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa M. Knowlton, MD, MPH principal investigator
Stanford University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis and Cholecystitis, Chronic, run by Cision Vision, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of structures identified (time frame: May 29, 2026 to October 11, 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.