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NOT YET RECRUITING
NCT07720505

COLOFLOW: Laser Speckle Contrast Imaging Versus Near-infrared Fluorescence Imaging With Indocyanine Green

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

Summary

COLOFLOW is a prospective observational study investigating whether Laser Speckle Contrast Imaging (LSCI), a dye-free and objective perfusion imaging technique, corresponds with the currently used subjective assessment of indocyanine green (ICG) fluorescence during colorectal surgery. In approximately 30 patients undergoing elective colon or rectal resection with primary anastomosis, both imaging modalities will be performed intraoperatively. The surgeons will base their clinical decisions solely on standard ICG fluorescence imaging, while LSCI measurements are collected for research purposes and do not influence treatment. Postoperatively, quantitative ICG parameters will be analysed and compared with LSCI perfusion maps to determine whether objective ICG analysis improves agreement with LSCI over subjective interpretation alone. In addition, the study will evaluate the feasibility of using the PerfusiX-IGS LSCI system during open colorectal surgery and describe postoperative outcomes, including anastomotic leakage. The ultimate goal is to contribute to more objective and standardized perfusion assessment during colorectal surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-08-01

Completion Date

2027-09-30

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Laser Speckle Contrast Imaging

Standard-of-care ICG fluorescence angiography for assessment of bowel perfusion and observational intraoperative Laser Speckle Contrast Imaging (LSCI) using the PerfusiX-IGS system. LSCI measurements do not influence surgical decision-making and are performed solely for comparison with subjective and quantitative ICG perfusion assessment.