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ICG Indocyanine Green in Reconstructive Surgery

NCT06129669 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2023-11-13

No results posted yet for this study

Summary

The success or failure of a reconstruction is largely related to the vascularization of the operated area. Near infrared fluorescence (also near infrared fluorescence angiography, NIR FA) with ICG administration is an innovative technique to quantify tissue perfusion. Based on the results obtained in other subspecialties, NIR fluorescence appears to be a promising way to quantify tissue perfusion in reconstructive surgery. Fluorescence research has previously been used in the context of microsurgery and breast reconstructions using implants, but structural objective determinations are lacking. Our study is successful if we are able to determine a cut off value for the absolute or relative perfusion parameters.

Conditions

  • Surgery
  • Fluorescence

Interventions

DRUG

Indocyanine green

Administration of ICG during surgery and recording of the fluorescence video to perform data analyses

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Caroline Driessen · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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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 NCT06129669 on ClinicalTrials.gov