Colorectal CancerPhase 1/2NCT07587619
Intraoperative Use of Oxygen Saturation Imaging to Assess Intestinal Perfusion
A Phase 1/2 study testing Fujifilm monitoring in people with Colorectal Cancer and Diverticulitis of Sigmoid, run by University of Southern California at 1 site in United States.
Trial summary
This will be a prospective, observational study of patients undergoing laparoscopic colorectal resection with anastomosis. After anastomosis creation and at the time of routine intraoperative flexible sigmoidoscopy, 4 mucosal StO2 measurements will be taken endoscopically and 4 corresponding serosal StO2 measurements… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Diverticulitis of Sigmoid
- What is being tested?
- Fujifilm monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2024to 1 Jul 2026
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older who can understand and provide informed consent
- Patients undergoing laparoscopic colorectal resection and intestinal anastomosis
Who cannot join
- Patients younger than 18 years old
- Patients who do not understand the study, are unable to provide consent, or refuse to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
This will be a prospective, observational study of patients undergoing laparoscopic colorectal resection with anastomosis. After anastomosis creation and at the time of routine intraoperative flexible sigmoidoscopy, 4 mucosal StO2 measurements will be taken endoscopically and 4 corresponding serosal StO2 measurements will be taken laparoscopically. Measurements will be recorded in a prospectively maintained database along with operative findings and clinical outcomes. Longitudinal data will be obtained via chart review to track longer-term outcomes.
Read the detailed description
This will be a prospective, observational study of sequential patients undergoing laparoscopic colorectal resection with intestinal anastomosis. After anastomosis creation and at the time of routine intraoperative flexible sigmoidoscopy, 4 mucosal StO2 measurements will be taken endoscopically using the Endoscope EC-740T/L: (1) proximal to the staple/suture line, (2) proximal edge of the staple/suture line, (3) distal edge of the staple/suture line, (4) distal to the staple/suture line. Concurrently, 4 corresponding serosal StO2 measurements will be taken laparoscopically using the Video Laparoscope EL-R740M or EL-R740M30. Measurements will be recorded in a prospectively maintained database along with operative findings and clinical outcomes. Longitudinal data will be obtained via chart review to track longer-term outcomes.
- Conditions
- Colorectal Cancer, Diverticulitis of Sigmoid
- Being tested
- Fujifilm monitoring
- Keywords
- perfusion, colorectal anastomosis, StO2, endoscopic perfusion monitoring
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fujifilm monitoringDevice
Monitoring with Fujifilm ELUXEO device endoscopically \& laparoscopically
| Study group | Role | What they receive |
|---|---|---|
| Fujifilm monitoring | Experimental | Fujifilm monitoring Receives: Device: Fujifilm monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leak
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start3 Sep 2024
- Primary completion17 Sep 2025
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Fujifilm
- Responsible party
- Principal investigator, Sang Won Lee, University of Southern California
- Investigators
- Sang Lee, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587619
- Sponsor's protocol ID
- 23-02233
- Status last verified
- Mar 2026
- First submitted
- 7 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of Oxygen Saturation Imaging to Assess Intestinal Perfusion
- ClinicalTrials.gov ID
- NCT07587619
- Acronym / sponsor ID
- 23-02233
- Conditions
- Colorectal Cancer, Diverticulitis of Sigmoid
- Keywords
- perfusion, colorectal anastomosis, StO2, endoscopic perfusion monitoring
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Fujifilm
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 14 May 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.
This will be a prospective, observational study of patients undergoing laparoscopic colorectal resection with anastomosis. After anastomosis creation and at the time of routine intraoperative flexible sigmoidoscopy, 4 mucosal StO2 measurements will be taken endoscopically and 4 corresponding serosal StO2 measurements will be taken laparoscopically. Measurements will be recorded in a prospectively maintained database along with operative findings and clinical outcomes. Longitudinal data will be obtained via chart review to track longer-term outcomes.
Detailed description
This will be a prospective, observational study of sequential patients undergoing laparoscopic colorectal resection with intestinal anastomosis. After anastomosis creation and at the time of routine intraoperative flexible sigmoidoscopy, 4 mucosal StO2 measurements will be taken endoscopically using the Endoscope EC-740T/L: (1) proximal to the staple/suture line, (2) proximal edge of the staple/suture line, (3) distal edge of the staple/suture line, (4) distal to the staple/suture line. Concurrently, 4 corresponding serosal StO2 measurements will be taken laparoscopically using the Video Laparoscope EL-R740M or EL-R740M30. Measurements will be recorded in a prospectively maintained database along with operative findings and clinical outcomes. Longitudinal data will be obtained via chart review to track longer-term outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fujifilm monitoring | Experimental | Device: Fujifilm monitoringFujifilm monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years or older who can understand and provide informed consent
- Patients undergoing laparoscopic colorectal resection and intestinal anastomosis
Key exclusion criteria (2 listed)
- Patients younger than 18 years old
- Patients who do not understand the study, are unable to provide consent, or refuse to provide 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 |
|---|---|---|
| Fujifilm monitoringMonitoring with Fujifilm ELUXEO device endoscopically \& laparoscopically | Device | Fujifilm monitoring |
Primary outcome
Anastomotic leak
Time frame: 30 days
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 20 May 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. This study is not recruiting at the moment.
Sang Lee principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fujifilm monitoring in people with Colorectal Cancer and Diverticulitis of Sigmoid, run by University of Southern California at 1 site 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anastomotic leak (time frame: 30 days). 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 20 May 2026.