Endoscopic Oxygen Monitoring During Colorectal Connections
Official title: Anastomotic Site Mucosal Oxygen Tension and Its Association With Anastomotic Complications
Run by Vanderbilt University Medical Center · NCT07467980 · Data updated 2026-11-12
This study tests a new endoscopic device that shows real-time tissue oxygen levels to help surgeons evaluate perfusion at the bowel connection in adults undergoing colorectal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | April 2027 |
| Study ends | April 2028 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT07467980 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older undergoing colo-rectal anastomosis who consent to participate.
✕Probably not a fit
Patients for whom the endoscopic oxygen tool does not change intraoperative decisions or who do not experience issues related to perfusion.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates a novel endoscopic imaging system that displays tissue oxygen saturation during colo-rectal anastomosis. Researchers will compare real-time oxygen data with standard perfusion assessment to see if oxygen levels can predict healing and reduce complications. Participation involves adults undergoing colorectal anastomosis at Vanderbilt University Medical Center, with intraoperative ICG-FA and endoscopic StO2 imaging. The study is sponsored by Vanderbilt with collaboration from FujiFilm HealthCare Americas and does not assign a treatment.
Why it matters
Potential benefit: If successful, real-time oxygen information could help surgeons make better decisions to promote healing and potentially reduce leaks.
How similar studies have gone: Prior approaches to assess tissue perfusion (like ICG-FA) have helped in some settings, but this endoscopic oxygen-monitoring method is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years). * Undergoing a colo-rectal anastomosis. * Patients who consent to study participation Exclusion Criteria: * Patients undergoing a revision surgery. * Participants with missing data. * Patients who do not undergo intraoperative ICG-FA and StO2 endoscopic imaging promptly after the formation of a viable anastomosis.
Where it's running
-
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Aimal Khan
- Email: aimal.khan@vumc.org
- Phone: +1 (615)343-4612
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.