Intraoperative Use of Oxygen Saturation Imaging to Assess Intestinal Perfusion

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT07587619
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fujifilm monitoring — DEVICE
    Monitoring with Fujifilm ELUXEO device endoscopically \& laparoscopically

Study Details

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.

Key Dates

Start date
Sep 3, 2024
Status verified
Mar 2026
Primary completion
Sep 17, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Fujifilm monitoring
    Fujifilm monitoring

Primary Outcome Measure

Anastomotic leak [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-

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