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Endoscopic COlorectal Mucosal Evaluation of Oxygen Tension

NCT07467980 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-03-12

No results posted yet for this study

Summary

Anastomosis refers to the surgical connection between two segments of the bowel, typically performed during colon and rectal surgeries to restore the continuity of the digestive tract after a section has been removed. It is necessary that the ends of the tissue at the anastomotic site are healthy (and capable of healing properly) as this will prevent dreaded complications like anastomotic leaks or strictures which can occur in almost a fifth of patients leading to increased hospital length of stay, costs, and mortality.

Currently, the most widely used method for assessing tissue viability during anastomosis is indocyanine green fluorescence angiography (ICG-FA). This technique involves injecting a fluorescent dye (indocyanine green) into the bloodstream, which highlights blood flow and tissue perfusion under a special camera. However, ICG-FA has limitations due to allergies and reliability due to the dye's rapid disappearance from the bloodstream. Additionally, the dye cannot be administered repeatedly. This study explores a new method of measuring tissue oxygenation by evaluating mucosal oxygen saturation (StO2) as an alternative to ICG-FA. By evaluating StO2 levels, the research aims to provide a more reliable and repeatable way to assess tissue viability without the drawbacks of using fluorescent dyes. Secondly, any blood supply interruption to the bowel will first lead to mucosal ischemia, which can potentially be reliably captured by measuring mucosal StO2 levels only.

In this single-center prospective single-arm study, we will evaluate whether mucosal StO2 levels are associated with or can predict anastomotic complications. This study will not involve any intervention that would affect the standard of care.

Conditions

  • Anastomotic Leak Rectum
  • Anastomotic Leak Large Intestine

Interventions

DEVICE

A novel endoscopic imaging system that displays real-time oxygen saturation levels

The imaging system in this study maps mucosal oxygen tension, where tissue first shows signs of hypoxia, rather than serosal oxygen tension, which has been the focus of previous studies

Sponsors & Collaborators

  • FujiFilm HealthCare Americas Corporation

    collaborator UNKNOWN

  • Vanderbilt University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2028-04-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07467980 on ClinicalTrials.gov