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Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction

NCT03757793 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2025-09-22

No results posted yet for this study

Summary

The study will evaluate the use of near infrared spectrometry (NIRS)in detecting early microvascular complications in deep inferior epigastric artery perforator (DIEP)-flap(s).

Conditions

  • Mastectomy
  • Breast Reconstruction
  • Flap Ischemia

Interventions

DEVICE

FORE-SIGHT ELITE monitor

At end of surgery, one sensor of the FORE-SIGHT Elite monitor is placed on the DIEP flap or two sensors in case of bilateral DIEP flaps for monitoring perfusion and oxygen consumption in the free flap. A control sensor of the FORE-SIGHT Elite monitor placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects normal tissue oxygenation. Data obtained from the FORE-SIGHT Elite monitor will be compared to data obtained from physical examination, which is standard of care for flap monitoring.

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Vera Saldien, MD · University Hospital, Antwerp

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-28
Primary Completion
2025-05-22
Completion
2025-09-01
FDA Device
Yes

Countries

  • Belgium

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 NCT03757793 on ClinicalTrials.gov